Parental Fears of Cochlear Implants in Saudi Arabia

By Abdallah Khamayseh, student of

the Master in Clinical Audiology and Hearing Therapy

Abstract

The aim of the study is to investigate parental perspectives on cochlear implantation and the process of making such a decision on behalf of their children. The questionnaire was developed in Arabic to assess the worries and difficulties experienced by the parents while deciding to implant for their children. The questionnaire was conducted under the supervision of an expert committee composed of consultants of speech and hearing diseases, and with recent developments in the medical devices industry, including cochlear devices, as well as the training of doctors, However, parents or guardians are still delaying and even avoiding it. There are many reasons that could turn them away, including the high cost of the procedure and the long-lasting rehabilitation sessions required afterward. To understand the main factors that may turn parents away from cochlear implantation, this questionnaire was developed with the five main components in mind (surgery, cost, rehabilitation, and decision-making). A cross-sectional study was conducted, and they were recruited via different social media channels. Data analysis was carried out using chi-square with the quality of relevance. The results showed that the important factor that raised fear in the minds of parents is the cost and price of cochlear devices and their accessories. In addition, there was a fear of lack of specialized cadres in some regions and cities due to the lack of centers that provide such services in the fields of audiology and speech and language rehabilitation

 

Keywords: cochlear implant, surgery, MRI, complications, gene therapy.

 

Parental Fears of Cochlear Implants in the Kingdom of Saudi Arabia

 

Cochlear implants (CIs) restore hearing for people with severe to profound hearing loss who received little or no benefit from hearing aids to help them acquire spoken language to achieve language skills like their typical hearing peers (Loizou, 1999). CIs are widely used worldwide and are considered the most successful option for managing childhood deafness since they were approved by the U.S. Food and Drug Administration in 1990 (Cosetti & Roland, 2010). Today, CIs are recommended for anyone suffering from severe to profound hearing loss from the age of 3 months up to 60 years (Cochlear, 2022). CIs have been improved significantly over time in terms of their internal and external design and specifications, in addition to rehabilitation and surgical approaches. Unipolar CIs were developed in 1959 by Djourno and Eyries. Since then, CIs have undergone significant changes to the form they have reached today. The latest generation of CIs enables hearing-impaired children to develop language skills like normal hearing peers and allows them to integrate into schools, particularly when appropriate rehabilitation programs are made accessible (Vieira et al, 2014).

 

Components of CI Devices

 

CIs consist of both internal and external components. The internal parts are the inner receiver and electrode array. The internal receiver is surgically placed under the skin in the mastoid bone, and the electrode array is inserted through the cochlear. The external parts are either placed behind the ear or fixed on the scalp. For some procedures, they are placed in a special cover attached to a belt connected to the clothes. The external components are a microphone, a speech processor, a transmitter, and a magnet. Their role is to receive sound waves from the surrounding environment through the microphone and send them to the speech processor, which converts these signals into electrical signals and transmits them to the internal receiver. The internal component consists of a receiver, a catalyst, an electrode system, and a magnet. The receiver coil receives the electrical signal from the external parts (the transmitter coil processes it and then transmits it as electrical pulses via the electrode array to the auditory nerve fibers in the spinal ganglion (Hainarosie et al., 2014).

 

How Cis Work

 

CI operators and researchers note that they share the same working principles across all manufacturers, despite the differences we see today in design and components (Pisoni et al., 2017). The microphone picks up sounds from the external environment surrounding them. It sends them via a wire to the speech processor, which converts the sound waves into digital signals according to individualized profiles that are programmed and stored in the speech processor according to specific parameters that match the patient’s degree of hearing impairment. Then these digital signals are transmitted to the external coil placed on the scalp. The outer loop sends the signs into the internal coil via radio frequencies encoding transcutaneous or via the skin. Then the receiver coil receives this information, processes it as electrical pulses, and transmits it to the electrode array implanted inside the cochlea through sealed electronic circuits. Each electrode is stimulated. The properties of the encoded signals in terms of frequency and level, in addition to the external processor’s setting, govern such stimulation (Zeng, 2004).

 

Cochlear Implantation Procedure

 

CIs are considered 1-day operations, meaning it is unnecessary to stay in the hospital more than 1 day after the operation. Implantation is performed under general anesthesia (Aldhafeeri et al., 2020). In Saudi Arabia, Riyadh, where Dr. Abdul Rahman Hajar and his colleagues performed 10 operations under local anesthesia, the external device was installed in the recovery room. The patients were immediately discharged after recovering from the effects of anesthesia (Aldhafeeri et al., 2020).

 

In CI procedures, the surgeon makes an incision in the skin behind the ear after ensuring that there is no hair around the wound, which sometimes requires removing hair from the targeted area. The assistant team, including the audiologist, performs a test to measure the patient’s response to the internal system. Then the surgeon or assistant closes the incision. After closure, the patient is transferred to the recovery room until the effects of the anesthetic are confirmed to be gone.

 

Complications of Cochlear Implantation Surgery and Risks Factors

 

Cochlear implantation, like any other medical surgery, can lead to complications and risks. CI manufacturers spend great resources to develop their devices so that these complications do not occur or are reduced to a level acceptable for future medicine and surgery (Joung, 2013). In addition, hand-on workshops for the medical and surgical staff are periodically offered in local and international conferences to ensure that the medical team is well trained to provide the highest standards level of care when performing this type of operation. In addition, such opportunities help the medical team gain sufficient experience to perform these surgeries with minimal complications, if any, and deal with difficulties in a professional manner that ensures patient safety (Clarke & Donaldson, 2018).

 

Cochlear implantation is a surgical procedure performed under general anesthesia and through which a foreign body is inserted into the human body. Depending on the individual’s immune system, some complications may occur because of the immune system’s reaction to this foreign substance (Migirov et al., 2009).

 

Despite the developments in the medical and technical cadres and companies’ efforts in research and studies, complications are sometimes inevitable and can be divided into two categories: special complications and minor complications. In this case, surgical complications include flap necrosis and improper electrode placement, and minor complications include incision dehiscence, infection, dizziness, facial nerve stimulation, and exophthalmos (Goudey et al., 2021).

 

Minor complications include infections in the middle ear, and in some cases, facial nerve paralysis, inflamed wounds, and dizziness, as well as additional issues during surgery such as the presence of the cerebral spinal cord (CSF) and tinnitus (Garrada et al., 2021). However, some cases of meningitis, resulting from malformation of the inner ear or leakage of cerebrospinal fluid, have been reported. It has also been suggested that the prevalence of meningitis infection was higher among children with positioning devices during the follow-up period compared to those with other implants (Reefhuis et al., 2003).

 

Cost of Cochlear Implantation

 

Cochlear implantation is one of the most expensive hearing solutions among hearing aids, as the average cost of a CI ranges from $30,000–50,000 (Kirsten, 2022). This depends on the manufacture, specifications, and characteristics of the device in addition to the patient’s medical insurance plans. The overall cost of the CI procedure includes pre-implant clinical examinations and surgery activation of the device and occasionally consists of the fee of follow up audio-verbal rehabilitation sessions (Deep et al., 2018).

Because the cost of the CIs is high, health systems in some countries force insurance companies to bear the costs of the device, especially because future costs may last throughout the patient’s life, such as consumable spare parts and rechargeable batteries.

 

CI and MRI Safety

 

Magnetic resonance imaging (MRI), performed by a radiologist, uses a large magnetic field to take a picture of the inner layers of the human body. Due to the high magnetic field that causes the temperature of the inner coil to rise (as it is made of metal), the temperature of this metal may also rise, or may be displaced from its position so that the CI patient feels pain, forcing the patient to have surgery again to replace the magnet (Bawazeer et al., 2019).

 

However, with recent developments in internal implant devices, though they vary from manufacturer to manufacturer, patients may undergo this imaging procedure under conditions that allow the internal magnet to be moved and redirected during the examination without surgical intervention. Such reorientation of the magnet can reduce torsional forces on the implant and tissue during the MRI procedure (U. S. Food and Drug Administration, 2021). Another manufacturer designed the internal magnet to be moved in a minimally invasive procedure before an MRI scan and replaced afterward (Babyhearing.org, 2019).

 

With all these efforts, designs, and developments in the internal devices, and although these examinations can be done safely with them, the manufacturers warn parents that they should inform the doctor of all the details of the device and their warnings. An identification card is used to ensure the patient’s safety. Another manufacturer designed the internal magnet to be moved with a simple surgical procedure before the MRI examination and replaced after the MRI examination (Health, 2021).

 

With all these efforts and these designs and developments in the internal devices, and despite the possibility of doing these examinations safely with them, the manufacturers stress the warning to the parents of the need to inform the doctor of all details about the device and carry his identification card to ensure the safety of the patient and his device internal parts (Hassepass et al., 2014).

 

Eligibility Criteria for Cochlear Implantation

 

To be able to judge whether an individual needs a CI, several conditions must be met to be eligible for the receiver of the implant (ASHA, 2015) including the following:

 

  • The CI candidate has severe hearing loss in both ears (71 decibels or more);
  • The cochlear implant candidate has used hearing aids regularly for no less than 3–6 months while performing audiological examinations using hearing aids, and the results are negative as they prove that the patient did not get the benefit from the hearing aids or that the benefits obtained are not sufficient.
  •  
  • Determining the period during which hearing loss occurred for the individual candidate for cochlear implantation and whether it was in the stage of birth or before or after language acquisition.
  •  
  • The individual candidate for cochlear implantation must undergo computed tomography or magnetic resonance imaging, or both to ensure that nothing is obstructing the CI; and
  • The individual candidate for CIs should have positive results in the psychological, mental, and neurological assessment of CIs.
  •  

Global Prevalence of Hearing Impairment

 

The prevalence of hearing impairment worldwide is of great importance to the World Health Organization (WHO), which reported in its recent publication that the number of hearing-impaired people is reaching nearly 430 million worldwide.

 

WHO (2021) expects the number of affected individuals to reach 700 million by 2050. In the United States alone, the number of hearing-impaired individuals reached 30 million, which is 12% of its total population (John Hopkins Medicine, 2011). In every 1,000 U.S. births, three newborns have hearing loss, which is one in 1,000 births who suffer from severe to severe-profound hearing impairment (Disease and Prevention, 2009). According to the National Centre for the Dissemination of Children with Disabilities in 2003, there are approximately 83 in 1,000 children in the United States with a so-called hearing impairment, which can cause lifelong consequences.

 

While Saudi Arabia ranked second in the Middle East in the number of people suffering from hearing loss, at a rate of 3.55% (WFD, 2008), Saudi Arabia is considered to have a high prevalence rate of hearing loss among children, with 13% of people suffering from hearing loss (Metwally et al., 2002; Sheikh & Zagzok, 2003). This is compared to the other countries of the Middle East that have reported a prevalence rate of 1.4% (Stevens et al., 2013). In Saudi Arabia, the sensorineural hearing loss prevalence rate reach 1.5%, and 0.7% had severe to profound hearing loss (Al-Abdul Jawad and Zakzouk, 2003). The rise in the prevalence of hearing impairment in Saudi Arabia is due to the high rate of consanguineous marriage (Zaqzouq, 2002), in addition to congenital diseases (Habib & Abdel Ghaffar, 2005), not to mention the hearing impairment that occurs in early childhood (Al-Ruwaili et al., 2012).

 

Cochlear Implantation Between Complexity and Simplification

 

Most children born with hearing impairment or hearing loss are healthy parents with no hearing issues (Alkhamrah, 2015) and do not have a sufficient background about hearing loss and how their child feel about it. Hence, the CI process was cumbersome, expensive, and complex. The reason for this was the necessity to focus on supporting parents with sufficient information about their child problems, which facilitates in their decision for partner in CI (Vieira et al., 2014). Both Sorkin and Zlatan (2008) indicated that parents who decided to undergo CI procedure for their children had no information about the CI or that the information they had was insufficient.

 

Studies have reported the need to provide parents with information about the whole process, the nature and technique of the device, programming, and post-implant speech rehabilitation (Sorkin & Zwolan, 2008). The decision-making process toward CIs is crucial, as deciding on behalf of children to undergo the cochlear implantation procedure process is a major step that cannot be reversed (Chakrabarty et al., 2004). As explained, CI differs from hearing aids as it is an internal part placed under general anesthesia in a surgical operation that the patient cannot remove on their own. It was necessary to have a full team of specialists with great experts in CIs to help and support parents in the decision-making process (Alzahrani et al., 2021). It is worth noting that many countries have this team. It is not limited to a particular country because of this team’s great importance and effective course in raising awareness and disseminating correct information about the CI process.

 

This team consists of audiologists, ear, nose, and throat specialists, surgeons, neurosurgeons, psychologists, social workers, and speech and language pathologists (ASHA, 2015). Despite the strong performance of this team, some parents prefer to hear from other parents who have gone through the experience and acquire more information about CIs (Vieira et al., 2014). Parent support groups are initiated by different CI device companies in the Kingdom of Saudi Arabia where they provide the contact numbers of experienced parents who have children with CI to the new parents of the CI candidate. The parents of the CI candidate can reach out to those who had preceded them with the experience of the cochlear implantation journey to familiarize them with the CI procedure, expectations, and outcome, which often successfully facilitates the decision-making process (Vieira et al., 2014). Most of the parents consider parent support groups complementary to the aforementioned medical interdisciplinary team.

 

Since 2020, the Jeddah Institute for Speech and Hearing (JISH) and medical rehabilitation in the Kingdom of Saudi Arabia has organized a periodic meeting that takes place every 2 months, bringing together old parents and new parents under the supervision of JISH’s specialists from the Department of Speech, Language and Audiology. Those meetings have greatly contributed to supporting parents and facilitating the task of decision-making regarding CIs (JISH, 2020). In general, parents still face fears about cochlear implantation in the Kingdom of Saudi Arabia, and this research study aims to reveal such fears that may negatively affect their decision.

The questionnaire used in this study is designed in Arabic to identify and detect the obstacles and challenges that parents face in relation to cochlear implantation was audited and reviewed by three speech pathologists and audiologists who hold doctorate degree in audiology and speech sciences. The study was approved by the Research Ethics Committee of the Faculty of Medical Rehabilitation Science at King Abdulaziz University in Jeddah, Saudi Arabia (Reference # FMRS-EC2023-004). The ready-made electronic forms in Google were used to develop and distribute this questionnaire. Ten colleagues tested this hearing science questionnaire to ascertain the questionnaire and easy access to information for the target audience. After that, an electronic link was created to distribute the questionnaire to social media (e.g., WhatsApp, Facebook, Twitter, LinkedIn). In addition, emails were sent to parents, who shared their contacts via WhatsApp groups and to those who were already receiving treatment sessions at the JISH after confirming that they gave their consents to be contacted by the center’s management for research purposes. They were to answer each phrase in the questionnaire by selecting one of the answers of yes, no, or maybe. Yes, and maybe responses scored 2 points, and no reactions scored 0 points. The inter-responses scored 1 point.

 

Before parents started filling out the questionnaire, they provided their consent. The parents’ questionnaire consisted of 13 items distributed as follows:

 

– Two items targeted parents’ fears about surgery, general anesthesia, and complications after cochlear implantation.

 

– Two items targeted parents’ fear about the possibility of losing natural hearing residue as a result of cochlear implantation procedure and their desire to wait for genetic or medical treatment to cure hearing loss.

 

– Two items targeted parents’ the suitability of the internal implant with the updates of the sound processor, its developments, and its safety toward radiography and MRI.

– One item targeted parents’ access to educational information about CIs, whether they were those who received the device, were candidates for implants, or who rejected implantation altogether.

 

– Six items targeted the financial and economic cost, whether concerning the cost of the device, spare parts, and accessories of CIs or related to the cost of post-implantation rehabilitation, programming, examinations, and other requirements necessary for the child to stay connected with the world around him/her.

 

Table 1. Questionnaire in English

 

Questionnaires

Yes

No

Perhaps

 
 

1

Is the reason for fear of cochlear implantation related to complications due to general anesthesia during surgery?

Yes

No

Perhaps

 

2

Is the reason for fear of cochlear implantation related to complications after surgery (infections, bleeding)?

Yes

No

Perhaps

 

3

Is the fear of cochlear implantation related to the lack of educational information about cochlear implants?

Yes

No

Perhaps

 

4

Is the fear of cochlear implantation related to losing the remnants of normal hearing?

Yes

No

Perhaps

 

5

Is the fear of cochlear implantation related to the desire to wait for a genetic or drug treatment for hearing impairment?

Yes

No

Perhaps

 

6

Is the fear of cochlear implantation related to the effect of magnetic resonance and x-rays?

Yes

No

Perhaps

 

7

Is the fear of cochlear implantation related to a suspicion of the incompatibility of the internal implant with the newer and updated generations of sound processors?

Yes

No

Perhaps

 

8

Is the fear of cochlear implantation related increased price or high cost?

Yes

No

Perhaps

 
 

9

Is the fear of cochlear implantation related to the high cost of spare parts, accessories, and batteries?

Yes

No

Perhaps

 

10

Is the fear of cochlear implantation related to your child not receiving the proper verbal and auditory rehabilitation?

Yes

No

Perhaps

 
 

11

Is the fear of cochlear implantation related to the limited time available for deciding about the operation?

Yes

No

Perhaps

 

12

Is the fear of cochlear implantation related to doubts about the competency of post-implant service providers (programming specialist, audiologist, speech pathologist)?

Yes

No

Perhaps

 

13

Is the fear of cochlear implantation related to the uncertainty about the quality of sound heard through the cochlea implants?

Yes

No

Perhaps

 

14

Are there other reasons not mentioned in the questionnaire?

Yes

No

Perhaps

 

 Please mention it if you find it………….

 

 

 


Statistical Analysis

 

This was a cross-sectional study where an online questionnaire was virtually distributed to families living in Saudi Arabia. Results were evaluated in terms of descriptive analysis to evaluate the overall responses. Then a chi-squared goodness of fit test was calculated for each question to determine statistical significance.


An analysis is significant on the grounds that it arranges and interprets data; at that point, structures that information into respectable data valuable and it is the process of cleaning and summarizing the results for better understanding. The below Figure 1 shows the overall process of data analysis.

 

Figure 1. Data analysis process

 

 

 

Figure 1 shows the process of data analysis starting by calculating descriptive analysis of general information about the participants and their children hearing status and devices. Then each question and its responses were identified, and then descriptive and chi-square analysis were applied. After which post hoc for chi-squared analysis was calculated as needed to determine the statistical significance. Finally, results were interpreted in relation to the research question.

Descriptive Analysis

 

The sample size of the respondents for this questionnaire was 150 families. Amongst the participants, 50%) (n=75) children used the cochlear devices, while 33.3% (n=50) children used hearing aids and two children used BAHA bone conduction device, i.e., a percentage of 1.3%, whereas the rest were bimodal using hearing aid and CI at the same time. Their number reached 15.3% (n=23). And Children used CI devices from different manufacturers, 27.3% (n=41) of the children used Cochlear, whereas 28.7% (n=43) used Med-El. Only 1.3% of children were users of Oticon Medical (n=2) while 8.7% were users of Advance Bionic (n=13). In addition, 34% were hearing aid users (n=51), and their devices were from various hearing aid companies (e.g., Oticon, Bear Navon, Hansaton, Phonak, Belton, Widex) (see Table 2).

 

When the parents were asked if they have concerns about CIs, 42% of families (n=63) answered that they do have concerns about CIs, while 34.7% families (n= 52), answered that they have no concerns about CIs, and the rest of the participants, 23.3% of families (n=35) answered that they might have some concerns. The Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2(1,150) =116, P<0.05 (see table 3). Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “maybe” were significantly lower than those who answered “no” and “yes” (P <0.001). Furthermore, the number of participants who answered “yes” approached significance (P=0.024, significance limit 0.0167) (see Table 2).

 

When asked if the cause of fear of CIs was associated with complications of general anesthetic during surgery, 56% (n = 84) of families with no concerns about it responded. While 26.7% of families (n=40) replied that they had such a fear, 17.3% (n = 26) replied that they might have concerns about complications of anesthesia. The Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2(1,150) =313.1, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “no” were significantly more that those who answered “yes” and “maybe” (P <0.001) (see Figure 2).

 

 

 

Figure 2. Percentage of parents fearing cochlear implantation related to complications from general anesthesia during surgery

 

When the parents were asked whether the reason for the fear of CIs were the complications that occur after the surgery, such as infections, bleeding or infection, 40% (n=61) of the families responded that they had no fears, and 38% (n=57) of the families answered that they do have such fear, while 21.3 % (n=32) of the families reported that that they may have this fear. The Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2 (1,150) =165.4, P<0.01. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “maybe” were significantly lower than those who answered “no” and “yes” (p <0.001). Furthermore, the number of participants who answered “No” did not reached statistical significance (0.05, significance limit 0.0167) (See Table 2).

 

When the parents were asked whether the reason for the fear were the lack of educational information about CIs from specialists and doctors in this field, 46% of families (n=69) answered that they had received sufficient information about implantation from specialists, and 42% (n=63) of the families reported that they did not receive any information about CIs, while 12% (n=18) of the families could not determine whether they obtained sufficient information about CIs or not. Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2 (1,150) =112.2, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “No” were significantly more that those who answered “Yes” and “Perhaps” (p <0.001) (see table 2).  

 

When the parents were asked whether the reason for the fear was the loss of the remnants of normal hearing in their children, 49% (n=74) of the families answered that they were actually afraid for children to lose the remnants of normal hearing, while 40% (n=60) of the families answered that they were not afraid of that; the remaining 10.7% (n=16) of the families answered perhaps the reason for the fear of CIs is the loss of the remnants of normal hearing for their children. Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2 (1,150) =591.5, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “Yes” were significantly more than those who answered “No” and “Perhaps” (p <0.001) (see Table 2).

 

When the parents were asked if the cause of fear was the desire to wait for genetic or medical treatment for hearing loss, 46% (n = 70) of families replied that they were already waiting for genetic or medical treatment for hearing problem, while 33.3% (n = 50) of families report that they are not waiting for treatment and fear that their children will lose their right to life, 20% (n = 30) of families were reluctant that this was the reason, and wanted to wait for treatment at the same time they wanted to provide early intervention with their children in CIs. The Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2 (1,150) =208, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “Yes” were significantly more that those who answered “No” and “Perhaps” (p <0.001) (see Figure 3).

 

 

Figure 3. Percentage of parents afraid of CI related to the desire to wait for G genetic or drug treatment for hearing impairment

 

When the parents were asked whether the fear of CIs is the effect of MRI and x-rays, 40% (n=60) of the families answered that they are afraid of that, while 40% (n=60) of the other families answered that they are not afraid. Only 20% (n=30) of the families who reported that they might have such fear (see Figure 3). The Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2(1,150) =204, P<0.01. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “perhaps” were significantly more that those who answered “No” and “Yes” (P<0.001) (see Table 2).       

 

Regarding the parents’ question about whether the reason for fear of CIs and the incompatibility of the internal implant for the new generations of the sound processor, 40% (n=60) of the families answered that they are afraid of the lack of adaptation of the internal implant to the new generations, while 33.3% (n=50) of the families had no such fears. Furthermore, 26.7% (n=40) of the families answered that this might be one of the reasons that make them fear CIs (see table 2). The Chi-squared test showed that there is no significant difference from a normal distribution amongst the choices χ2 (1,150) =52, P>0.05.

 

When the parents were asked if the fear of CIs was caused by the cost of the device, the majority, 56.7%, of the families (n = 85) replied that the cost of the device was too high, while 30% (n = 45) of the families replied that the cost was not a concern. Furthermore, the 13.3% of households (n = 20) noted that they might be concerned about the cost. The Chi squared test showed that there is a significant difference from a normal distribution amongst the choices χ2 (1,150) =475, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “Yes” were significantly more that those who answered “No” and “Maybe” (p <0.001) (see Figure 4).       

 

 

Figure 4. The percentage of parents afraid of CI related to the rise in its price

 

Regarding the question about the parents’ fears about CIs due to the high cost of spare parts and hardware accessories such as wires, batteries, coils and others, 61.3% (n=92) of the families, answered that they were afraid and were unable to bear the costs of cutting consumer devices, which may be periodically close, while only 26% (n=40) of the families had no such concerns. In addition, 12% (n=18) of the families answered that spare part cost is could be a concern of CIs (see  Figure 5). The Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2 (1,150) =549.3, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “Yes” were significantly more that those who answered “No” and “Maybe” (P<0.001).

 

 

Figure 5. Percentage of parents afraid of CI related to high cost of spare parts, accessories, and batteries

 

With regard to the parents’ question about whether the reason for the fear is the child’s failure to receive the appropriate verbal and auditory rehabilitation, 52% (n=78) of the families responded that they are concerned that their child would not receive the correct speech rehabilitation after cochlear implantation, and 32.7% (n=49) of the families had no such concerns, while only 15.3% (n= 23) of the families answered that this may be a concern. Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2(1,150) =380.2, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “Yes” were significantly more that those who answered “No” and “perhaps” (P<0.001) (see Table 2).

 

When the parents were asked whether the fear of a cochlear implant was prompt to decide on the surgery, 53.3% (n = 80) of households answered “No”, while 31.3% (n = 47) who answered “Yes”, 15.3% (n = 23) replied that it might also be a reason. The Chi-squared test showed that there is a significant difference from a normal distribution amongst the choices χ2(1,150) =382.7, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “No” were significantly more that those who answered “Yes” and “Perhaps” (P<0.001) (see Table 2)

 

When the families were asked about the efficiency of service providers and specialized centers after the cochlear implantation operation, the reason for their fear of the CI operation, 42% (n=63) of the families, answered that they were not afraid of it, and 36.7% (n=55) of the families answered that they had great doubts about the efficiency of the CI. A total of 21.3% (n=32) of the families answered that they might have doubts about the efficiency of service providers after cochlear implantation. The Chi squared test showed that there is a significant difference from a normal distribution amongst the choices ꭓ2(1,150) =380.2, P<0.001. Post hoc testing by partitioning the data and a Bonferroni adjusted alpha (0.05/3) show that participants who answered “No” were significantly more that those who answered “Yes” and “maybe” (P<0.001) (see Figure 6).

 

 

 Figure 6. Percentage of parents afraid of CIs related to efficiency of post-cochlear providers.

 

Regarding the fact that the fear of cochlear implantation is due to the nature of the sound heard through the cochlea and that it is far from the normal sound we hear. A total of 50% (n=75) answered that they are afraid of CIs for this reason, while 29.3% (n=44) of the families were as not the reason for their fear, while 23.7% (n=31) of the families answered that it may also for their fear of CIs, Chi squared test showed that there is a significant difference from a normal distribution amongst the choices ꭓ2(1,150) =193.7, P<0.001 (see Table 2).

 

Figure 7. Data Tables showing the percentage of respondents for each question. Highest response rate is highlighted in green, medium response rage is in yellow and lowest response rate is highlight in red. 

 

 

 

 

 

The summary of the whole questionnaire is represented below, in which we can identify which question is significant for us, and which is not.

 

Table 2. Questionnaire Analysis Summary: 1st column is the question; 2nd column is the fear present “Yes” indicate that fears were present regarding the corresponding question while “No” represent fears were not present in regard to the corresponding question; 3rd column is statistical test (chi-squared and post-hoc testing).

 

Question

Fears

Remarks

 

 

 

1-     Is the fear of cochlear implants the uncertainty about the efficiency of post-implant service providers (programming engineer, audiologist, speech pathologist?

Yes

·       p value                             0.006

·       Post  Hoc (Significance) Yes

 

 

 

2-     Is the reason for the fear of cochlear implantation is the complications that occur after the surgery, such as infections, bleeding, or infection?

No

·       p value                            0.007

·       Post Hoc (Significance)     NO

 

 

 

3-     Is the reason for the fear of cochlear implantation is the fear of complications from general anesthesia during surgery?

No

·       p value                            0.000

·       Post Hoc (Significance)    NO

 

 

 

4-     Is the fear of cochlear implantation the speed in making the decision about the operation?

No

·       p value                                 0.000

·       Post Hoc (Significance)     NO

 

 

 

5-     Is the fear of cochlear implants the lack of educational information about cochlear implants?

No

·       p value                               0.000

·       Post Hoc (Significance)      NO

 

 

 

6-     Is the fear of cochlear implantation that your child does not receive the correct audio-verbal rehabilitation?

Yes

·       p value                                0.000

·       Post Hoc (Significance)      Yes

 

 

 

7-     Is the fear of cochlear implants a suspicion of the inappropriateness of the internal implant for modern generations of sound processors?

No

·       p value                               0.135

·       Post Hoc (Significance)     NO

 

 

 

8-     Is the fear of cochlear implantation the loss of the remnants of normal hearing?

Yes

·       p value                        0.000

·       Post Hoc (Significance) Yes

 

 

 

9-     Is the fear of cochlear implantation the desire to wait for a genetic or drug treatment for hearing impairment?

Yes

·       p value                            0.000

·       Post Hoc (Significance)   Yes

 

 

 

10- Is the fear of cochlear implants the effect of magnetic resonance imaging and x-rays on it?

No

·       p value                             0.002

·       Post Hoc (Significance)    No

 

 

 

11- Is the fear of cochlear implants uncertainty about the nature of the sound heard through the cochlear?

Yes

·       p value                             0.000

·       Post Hoc (Significance)   Yes

 

 

 

12- Is the fear of cochlear implants the high cost of spare parts?

Yes

·       p value                             0.000

·       Post Hoc (Significance)   Yes

 

 

 

13- Do you have concerns about cochlear implants?

Yes

·       p value                           0.019

·       Post Hoc (significance)     Yes

 

 

 

14- Is the fear of cochlear implants the rise in its price?

Yes

·       p value                             0.000

·       Post Hoc (Significance)   Yes

Recently, CI use has spread exponentially, with nearly 300,000 people receiving cochlear devices, 40,000 of whom are children, and 60,000 in adults and the number is increasing steadily in the United States (Yawn et al., 2015). This is due to the evolution of the CI devices advancing from the unipolar to multipolar systems, which contributed significantly to an improved auditory perception in different listening environments (Zeng, 2004). Not to mention the updated form of the newer CI devices (kanso1 and kanso 2) and MED-EL devices (Rondo 1, 2, 3), which can be placed on the scalp without the need for cables. In addition, the enhanced positive outcomes reported regarding the acquisition of linguistic skills for those who obtained CI devices at early ages due to the enrollment in the appropriate early detection and intervention hearing screening programs, raised the awareness among the population about the positive outcomes of cochlear implantation. Recent studies indicated how the importance of early intervention in diagnosis and treatment greatly contributes to the development of auditory and social skills of children with hearing impairments; the study reported significant improvements in children who received CIs at early ages compared with those who obtained them later in life (May-Mederake, 2012).

 

 With all the developments that have taken place, there is still a significant delay in people’s decision-making about CI, risking their children to miss out on the critical period for language acquisition which takes place at a very early age. As a result of the challenges faced by parents in making informed decision about cochlear implantation as early as possible, in this research study we highlight the greatest challenges and concerns faced by parents: (a) the high cost of the device; (b) higher costs incurred by parents for spare parts and accessories for life; and (c) the substantial resources required by parents for the rehabilitation process, which include rehabilitation, programming, transportation and housing, especially in areas where these services are not provided (d) the competence of service providers after the CI process, which is the efficiency of programming and rehabilitation specialists. Waiting for gene or drug therapy to treat hearing loss, and (f) fear of loss of natural hearing residue because of CI and the uncertainty about the quality of sound heard through the CI device.

 

In this study, parents faced a significant challenge over the high cost of CI, with 85 families (65.67%) having faced a significant challenge in providing the necessary fees for the cochlear implantation procedure and the tool to their children, making them look for other resources that may provide financial assistance or wait until the amount is provided through government or non-profit organizations. As this challenge makes them hesitant or possibly prevents them from acquiring CI devices for their children, it means delaying early intervention and missing the critical period of language acquisition in children. Parents’ concerns about the high cost of cochlear devices were not limited to the Saudi community. Through the review of literature and previous studies, the high cost and provision of cochlear devices was a major challenge for the people, as a previous study in South Africa reported, the high cost of cochlear devices poses a major challenge for parents and force them to delay or rejected CI (Bhamjee et al., 2019). In line with our current study findings, Khan et al., (2019) reported that many cases of cochlear implantation received these devices from their own expense and incurred the costs of these devices.

 

The cost of the cochlear implantation procedure and CI devices were not the only major concern for the families of children hearing impairments, 92 families of participants (61.33%) reported that they face a significant challenge in increasing the costs of spare parts and accessories for their children’s CI devices as the devices require frequent maintenance. The CI device is worn by the child for life and, as a small device, it needs periodic follow-up and preventive maintenance and changing consumables such as batteries, cables, coils, and other pieces. Parents must allocate monthly budgets to the lifelong follow-up to ensure that the child remains in contact with the environment and community uninterrupted; in many cases they allocate monthly allowances that may exceed their monthly income. Not to mention the struggle with loss or damage of the external speech processor, which could be broken or damaged due to the various children’s activities which in turn can cost large fortune, adding additional burdens on parents.

 

To have a clearer idea about the cost of spares parts that parents need to deal with, cochlear devices agents in Saudi Arabia, Al Qubaisi Cochlear Devices Agents, Atiyeh Medical devices agents MED-EL, as well as Gulf Medical Agents Advance Bionic (AB) were contacted to establish an estimation of the monthly cost of CI devices. The cost of an external speech processor is at least US $15,000, which can take years to save. Expensive consumer pieces such as a cable cost $200 and up to $300 in some companies; a disposable battery costs $60 per device consumes 60 batteries per month for one child, which means $120 monthly for just batteries, while a rechargeable battery cost is estimated at $320. With a review of previous literature, there was a study of 52 families in Egyptian society, where interviews were conducted with the families of children with CI, where 60-80% of the parents reported that they faced a significant challenge in rising spare parts prices, which in a course corresponds to our current research study, as were other studies that discussed the challenges of the high cost of spare parts (Salah et al., 2019).

 

One of the challenges facing parents of children with CIs is that cochlear implantation procedure and obtaining the external speech processor is only the initial stage of the treatment journey, and the bulk of the treatment phase is the ensuing rehabilitation and follow-up. We all know too well the importance of rehabilitation and speech therapy in the CI journey, which is the bulk of the treatment. It includes treatment sessions for aural rehabilitation and language rehabilitation, which is estimated at $300 per month for these sessions. People living in the same area as those centers and rehabilitation clinics at a monthly rate may need $100 for transportation and fuel. It is expected to reach $700 for those living in an area close to the area where these centers are located. Sometimes people may have to book flights to get to such centers, requiring them to secure flight costs and hotel accommodation or may force them to move and live in this area, which is estimated to cost $1,000 per month. In addition, it is important not to forget that there is also frequent follow-up with audiologists to ensure that the child has appropriate access to sound and the speech processor is mapped appropriately such sessions may reach $120 per visit. All these costs must be considered during the CI journey. Fifty-five families (36.76%) reported that this cost caused them a new challenge in the CI journey with their children, which requires them to carefully decide how to secure all these costs, especially since the rehabilitation’s journey is not a short period and needs regular follow-up. In line with our findings, a previous study carried out through an in-person interview with families of children with CI calculated the costs incurred by families, which was that families spent a significant amount of time, effort and money in attending CI rehabilitation programs (Sach et al., 2019).

 

It should be noted that very few schools in Saudi Arabia are dealing with CIs users, and they lack competencies in the areas of speech, language, and hearing, forcing parents to move out of place for adequate therapeutic sessions during their CIs journey. All of these factors pose a major challenge for parents to agree to proceed with CI, pushing them to delay the implant or perhaps move away from it altogether and be content with the results from hearing aids.

 

Lastly, many parents are thinking about waiting for medication or genetic therapy to treat their children hearing loss. Those parents are hopeful that their children will get rid of this problem without use of medical devices such as cochlear implants. However, waiting for a therapeutic treatment may be a main reason behind the delay in verbal speech acquisition reported in deaf children who did not opt to use CI as those children missed the optimal time of the critical period where language acquisition is developed the most, 70 families (46.76%) of the respondents agreed that waiting for a cure is a concern. Finally is another aspect that provokes concerns and fears is the quality of the sound that the child would be hearing via the CI devices; 75 families (50%) agreed that the uncertainty about the quality of the sound signal elicit fears and doubts about CI.

 

The challenges faced by parents that forced them to reject CI, do it later or possibly turn it around altogether meant financial cost and treatment and rehabilitation services on the CI journey. To overcome these problems, we need a comprehensive national program that ensures the treatment journey from A to Z, in which the Ministry of Health partners with medical insurance companies to contribute to the continuous support of cochlear implant recipients. The current national program, which is supervised by the Ministry of Health and ordered by the Custodian of the Two Holy Mosques, King Salman bin Abdul-Aziz, is responsible for securing the device and its implantation in its public hospitals. This incurs the role of medical insurance companies with the inclusion of therapeutic sessions, consumer parts, and supplies in their schedule of benefits and ensures the usage on behalf of the parents by contracting with the treatment centers and cochlear agents and their coverage with medical insurance in the coverage of insurance for pre-implant and post-implant examinations as well as calibration and programming.

 

One of the issues of medical rehabilitation is the lack of access to qualified medical clinicians in remote areas; thus, the finding of this study indicates needs for the investment of opening centers throughout the kingdom to improve the access of CI recipients to appropriate rehabilitation session, saving time, effort, and money. There is also an urgent need for a parental training program on how to deal with their children within the home and surrounding area that complements the children’s language rehabilitation program through medical rehabilitation and cochlear transplantation centers.

 

This study has some limitations regarding its expansion. For example, one of these constraints was to study the answers by geographical region and CI’s impact on parents’ responses. And the measurement of parents’ educational level was one of the limitations that affected the nature of the study and some of parents we couldn’t reach because they had an old phone that did not have access to social media.

 

In future studies, emphasis should be focused on the nature of the geographical area, as well as the educational level of the parents and the costs incurred by the parents in a more detailed manner, which will help us to create a database for each organization and work on it separately to advance the best therapeutic options in the field of cochlear implantation.

 



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