|Year : 2021 | Volume
| Issue : 1 | Page : 21-25
Pilot study: Cochlear implant nonuse secondary to maintenance issues in saudi Arabian children – unilateral versus bilateral
Turki Hagr1, Shaza Saleh2, Abdulrahman Hagr2
1 College of Medicine, Al-Imam Muhammad Ibn Saud Islamic University, Riyadh, Saudi Arabia
2 King Abdullah Ear Specialist Center, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia
|Date of Submission||15-Aug-2020|
|Date of Decision||13-Sep-2020|
|Date of Acceptance||25-Sep-2020|
|Date of Web Publication||08-Mar-2021|
College of Medicine, Al-Imam Muhammad Ibn Saud Islamic University, Riyadh
Source of Support: None, Conflict of Interest: None
Introduction: The study aimed to explore the implanted children's parents' attitudes toward what could be considered an acceptable period to address speech processors (SPs) dysfunction and indirectly of cochlear implantation (CI) nonuse secondary to SP's problems in unilaterally and bilaterally implanted patients. Methods: A questionnaire was administered to CI recipients from multiple centers to investigate how long it took them to seek help in case of a SP problem and how long it took them to receive a replacement/loaner device in unilateral and bilateral CI cases. The questionnaire also investigated whether they had a backup device or not. Results: One hundred and forty-three CI recipients' parents filled the questionnaire. Thirty-two percent of unilaterally implanted recipients had backup SPs in comparison to 18% only of the bilaterally implanted, yet statistically significant correlation was found between the time it took them to seek help and whether the recipient had a unilateral or bilateral CI, χ2 (5, n = 143) = 11.07, P < 0.05). Without having a backup SP, 67% of unilaterally implanted individuals sought help immediately versus 61% of the bilaterally implanted. Conclusions: CI nonuse secondary to SP issues was found to be a problem which could be due to delayed reporting or device replacement issues. SP requires daily ear specific testing and high maintenance to ensure consistent use which can be partially solved by backup devices. Some CI recipients and their families might perceive having a second CI as a backup which may contribute to the delay in seeking help for faulty SPs among the bilaterally implanted CI recipients.
Keywords: Bilateral, cochlear implant, maintenance, nonuse, pediatrics
|How to cite this article:|
Hagr T, Saleh S, Hagr A. Pilot study: Cochlear implant nonuse secondary to maintenance issues in saudi Arabian children – unilateral versus bilateral. Saudi J Otorhinolaryngol Head Neck Surg 2021;23:21-5
|How to cite this URL:|
Hagr T, Saleh S, Hagr A. Pilot study: Cochlear implant nonuse secondary to maintenance issues in saudi Arabian children – unilateral versus bilateral. Saudi J Otorhinolaryngol Head Neck Surg [serial online] 2021 [cited 2021 Jun 25];23:21-5. Available from: https://www.sjohns.org/text.asp?2021/23/1/21/310988
| Introduction|| |
Cochlear implantation (CI) is increasingly used to provide hearing to deaf and hard of hearing individuals who experience little or no benefit from amplification. CI has many benefits whether it was unilateral or bilateral and to receive these benefits patients must use their device. CI usage is crucial for auditory and linguistic skills development especially in children, as usage decreases the benefits of the implant also decrease and skills are lost and might need reprogramming of the device.
Bilateral CI is becoming the standard of care for children with severe to profound hearing loss in developed countries around the world (National Institute on Deafness and other Communication Disorders, 2011). Having a bilateral CI has many benefits such as more environmental awareness, localization, better speech perception especially in noise, speech production, language development, social and emotional development, and literacy and academic outcomes.
The CI external device (ED) consists of the sound processor, the microphone (s), the battery compartment, the coil/headpiece, and cable. Each of these components is susceptible to technical failure or loss. As a medical device, it is vulnerable to dysfunction, and without its proper function, the implantable device is not able to stimulate the cochlea. Many factors could affect the use of the ED. Device nonuse could be due to multiple factors such as psychological factors, social issues, age of implantation, financial issues, lack of family support, peer pressure, problems in the programming of the CI speech processor (SP), perception of limited benefit from CI, physiological reason for lack of benefit (e.g., central auditory processing disorder), or device-related whether it was a hard failure or soft failure.
Nonuse is a known issue that many studies have looked into.,, While they explored different factors of nonuse, they were not focusing on the device itself and the issues that could arise from it which can compromise its usage. In this pilot study, we focused on the factors that might delay or prevent the implanted child from having a functional CI device after detecting dysfunction. We did not find similar studies done to evaluate this critical issue. The outcome may help clinics and/or manufacturers to monitor and support these issues as well as help the CI centers to provide appropriate support to the patients' and children's caregivers.
The results of this pilot study can assess the extent of CI nonuse in Saudi Arabia and suggest solutions for the problem whether it was from the CI recipient's side or that of the service provider.
| Methods|| |
Ethical approval No. 14/251/IRB and Research and Development approval was obtained for this project from the Institutional Review Board at King Saud University.
Participants were recruited from a tertiary university hospital which is the largest CI center in the Kingdom of Saudi Arabia with wide collaborations with other CI centers in the kingdom. Families of pediatric CI recipients from multiple centers were personally invited to fill out an online questionnaire and through a national pediatric CI users association's advertisement to recruit for the study via its social media outlets.
The inclusion criteria were that the participants had a minimum of 6 months CI experience and were pediatric CI recipients. Incomplete responses were excluded from the study.
The questionnaire consisted of initial questions to ensure that responses confirm that the children fulfilled the inclusion criteria, followed by six main questions with high-quality illustrations and was filled out using Google forms anonymously to increase the credibility of the answers and they were given 3 days to complete it. Multiple-choice questions were used to assess if the patient was unilaterally or bilaterally implanted, if they had a back-up SP, coil, and/or cable to see if they had the necessary kit to troubleshoot and fix the issue as soon as possible. We also considered the time it took them to report the problem to evaluate family's compliance in term of showing early to fix the problem after they report the problem we asked them how long it took to receive a replacement device to assess the total time of CI nonuse secondary to availability/accessibility of replacement parts as well.
Patients were divided into two groups, unilateral and bilateral, and each group was further divided into three subgroups based on the availability of a backup SP and a troubleshooting kit which consists of a backup coil and cable. The time of nonfunctioning SP was set to 2 weeks because after 2 weeks patients may need reprogramming. Data were analyzed using IBM SPSS Statistics for Mac, version 23 (IBM Corp., Armonk, N. Y., USA); Shapiro–wilk test was used to assess the normal distribution of the sample because it is the recommended test for such case. The Wilcoxon signed-rank test was used to assess the correlation between being unilaterally or bilaterally implanted and the time it took them to report the problem, whether they had a troubleshooting kit and/or a back-up SP was considered.
| Results|| |
A total of 143 CI recipients filled the questionnaire. A statistically significant correlation was found between the time it took them to seek help and whether the recipient had a unilateral or bilateral CI, χ2 (5, n = 143) =11.07, P < 0.05) [Figure 1]. 29 (32%) of unilaterally implanted recipients had backup SPs and only ten (18%) of the bilaterally implanted did [Figure 2]. Without having a backup SP, 41 (67%) of unilaterally implanted individuals sought help immediately versus 26 (61%) of the bilaterally implanted, also nine (20%) of bilateral recipients waited for more than a month [Figure 3].
|Figure 1: Comparison of reporting time between the unilaterally and bilaterally implanted|
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|Figure 2: Percentage of unilaterally and bilaterally implanted recipients that have a backup device|
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|Figure 3: Comparison of reporting time between unilaterally and bilaterally implanted recipients that don't have a backup device|
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Two (7%) of unilateral patients with a backup waited for more than 2 weeks to seek help in comparison to bilaterally implanted whom two (20%) of them waited that long [Figure 4].
|Figure 4: Comparison of reporting time between unilaterally and bilaterally implanted recipients that have a backup device|
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Twenty-five (96%) of unilaterally implanted patients who had a troubleshooting kit sought help in <2 weeks [Figure 5]. Comparing waiting time to receive a replacement/loaner device, 51 (56%) of unilaterally implanted patients waited <2 weeks and 39 (43%) of them waited for more than 2 weeks whereas 28 (52%) of bilaterally implanted waited for <2 weeks and 25 (47%) of them waited for more than 2 weeks [Figure 6].
|Figure 5: Comparison of reporting time between unilaterally and bilaterally implanted recipients that have a troubleshooting kit|
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|Figure 6: Comparison of waiting time to receive a backup device between the unilaterally and bilaterally implanted recipients|
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A detailed summary of reporting time is shown in [Table 1]. Also, [Table 2] shows in detail how long it took them to receive a backup/replacement device.
|Table 2: Detailed summary of waiting time to receive a backup/replacement device|
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| Discussion|| |
This study shows that CI nonuse secondary to ED issues was a big problem in Saudi Arabia which could be due to delayed reporting or device replacement issues. This kind of nonuse has a major impact on the pediatric age group who are in bad need of hearing to acquire the language and be able to communicate with the community orally and limiting all the need of sign language. Moreover, this delay could disturb the whole scheduled rehabilitation plan and ED programing.
Bilateral CI has proven to have many advantages compared to unilateral. However, our data shows one hidden advantage for patients with unilateral CI where we found that they seek help earlier than those with bilateral CI in general. This fact could explain the inconsistent benefits of bilateral CI compared to unilateral in published articles. This nonuse in bilateral CI patients discovered in this study can be a confounding factor that should not be ignored in future comparisons between unilateral and bilateral CI.
A small minority of unilateral CI recipients that don't have a back-up device reported the problem in more than 2 weeks which indicated that they are more compliant than unilateral patients with back up devices and bilateral CI recipients. Therefore, we advise centers and caregivers to avoid backup devices and utilize this cost for bilateral implantation.
The CI ED requires high maintenance to ensure consistent CI use which can be partially solved by having backup devices from the patient perspective. This needs to be investigated thoroughly to ether give these backup devices under professional control and frequently upgrading their program according to objective measures or warning caregivers from using them as extra battery option or fitting the child without direct control of highly specialized audiologists.
Our result shows that unilaterally implanted patients with backup devices report their problem earlier than patients with bilateral implants, which could be a benefit that their hearing is not affected from the care giver's point of view. This important point needs to be evaluated by their performance in speech and education, although we expect deterioration in their long-term performance compared to unilaterally implanted children. However, in the short term, these effects may not be noticed by the caregivers. Another point, caregivers may not notice problems in bilaterally implanted children who are too young to report the problem because the child could be responding from one ear. Hence, counseling caregivers should emphasize checking each device separately for bilaterally implanted children. This delay should not be overlooked by caregivers to capitalize on the benefits of using bilateral CI.
In our center and many centers in Saudi Arabia, we do not provide a backup sound processor and we do not program the backup sound processor which means that the caregiver reassures themselves by the backup sound processor that has a program that might have not been adjusted or monitored by the CI team. This practice should be investigated to make sure that all backup devices are programmed with the latest fitting.
Long waiting for more than 2 weeks in bilaterally implanted patients could indicate that CI recipients caregiver perceive having a second CI as a backup which may explain the delay in seeking help for faulty ED among the bilaterally implanted CI recipients and can cause CI nonuse. This problem should not be overlooked in counseling the caregivers preoperatively and frequently if required in scheduled follow-up visits.
Distributing the questionnaire in social media outlets was useful in getting quick responses that can be utilized in the future for more screening. Our legitimate concern is those children whom their caregivers are not familiar with social media. We tried our best to attract parents to participate in this study by close-set options, minimum input so no time or effort consumption could lower the sample size, we were surprised with the fast responses which encouraged us to do more studies in the future.
Further research is needed to explore other factors that could be a cause of CI nonuse, apply it to an age-specific group, have a larger sample, socioeconomic status, level of parent education, the city of residence, and distance to the closest vender's office.
As it is difficult for children to express their problems especially infants, we recommend that companies consider adding a warning light to all devices in case of any problem to help the parents/caregivers in seeking help as fast as possible and reduce the CI nonuse. We also recommend that the companies add to the SP a new feature to provide give the hospital/CI center notifications of problems or nonuse so they can provide early intervention and prevent the nonuse cost as well as the time and visits required to reprogram the device after a long time of nonuse.
Cochlear implants are very expensive devices; therefore, this study provides insurance companies and funding agent insights and ideas for children to better support their caregivers/parents and enable better utilization of the implants for maximum benefits; this will indirectly help other caregivers/parent to follow-up regularly and take better care of their children's CIs.
| Conclusions|| |
CI nonuse secondary to ED issues was found to be a big problem in Saudi Arabia which could be due to delayed reporting or device replacement issues. CI recipients and their families perceive having a second CI as a backup which may contribute to the delay in seeking help for faulty ED among the bilaterally implanted CI recipients and can cause CI nonuse. Solutions could include counseling and facilitating the provision of replacement devices.
The project was supported by King Saud University, Deanship of Science Research, King Saud University, Riyadh, Saudi Arabia. This was one of the recommended research projects by the Saudi Otorhinolaryngology Society.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2]