|Year : 2022 | Volume
| Issue : 3 | Page : 106-113
Remote programming of cochlear implants: The coronavirus disease 2019 pandemic experience
Isra Aljazeeri1, Shaza Saleh2, Maram Alkahtani3, Fida Almuhawas2, Yassin Abdelsamad3, Abdulrahman Hagr2
1 Department of Otolaryngology, Aljaber Ophthalmology and Otolaryngology Specialized Hospital, Ministry of Health, Ahsa; King Abdullah Ear Specialist Center, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia
2 King Abdullah Ear Specialist Center, College of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia
3 Department of Research, MED-El GMBH, Riyadh, Saudi Arabia
|Date of Submission||07-May-2022|
|Date of Decision||06-Jul-2022|
|Date of Acceptance||12-Jul-2022|
|Date of Web Publication||30-Sep-2022|
Dr. Isra Aljazeeri
King Abdullah Ear Specialist Center, College of Medicine, King Saud University, P.O. Box 245, Riyadh 11411
Source of Support: None, Conflict of Interest: None
Objectives: This work aimed to study the feasibility and stakeholders' satisfaction with remote programming (RP) of cochlear implants. Materials and Methods: This prospective study was conducted in a tertiary referral ear specialist center. The audiological and speech outcomes of the patients were measured. The satisfaction of all stakeholders, including remote experts (REs), local hosts (LHs), and patients/families, was evaluated through detailed questionnaires. Results: Twenty-two RP sessions for 15 patients were included. The satisfaction levels of LH, REs, and patients/families with the RP sessions were all above 6/10, 5/10, and 7/10 Likert scale, respectively (with 10/10 being the most satisfied). All stakeholders would recommend RP to others. There was no statistically significant difference in the audiological outcomes including for Pure Tone Average (PTA4), speech reception threshold, and word recognition score between the session preceding RP, RP session and the session after the RP (Wilcoxon test, P value ranging from 0.06 to 0.73). Data logging after the RP session showed a higher duration of speech processor usage (mean difference 0.64 h/day, Wilcoxon test, P = 0.006). Conclusion: In the era of coronavirus disease 2019 pandemic, RP of confidence interval (CI) can be a safe, feasible, and satisfactory alternative to classical in-office programming sessions. Further studies and efforts should be done to make the RP an available option for CI recipients to save time and cost.
Keywords: Audiology, cochlear implant, coronavirus disease 2019, otolaryngology, programming
|How to cite this article:|
Aljazeeri I, Saleh S, Alkahtani M, Almuhawas F, Abdelsamad Y, Hagr A. Remote programming of cochlear implants: The coronavirus disease 2019 pandemic experience. Saudi J Otorhinolaryngol Head Neck Surg 2022;24:106-13
|How to cite this URL:|
Aljazeeri I, Saleh S, Alkahtani M, Almuhawas F, Abdelsamad Y, Hagr A. Remote programming of cochlear implants: The coronavirus disease 2019 pandemic experience. Saudi J Otorhinolaryngol Head Neck Surg [serial online] 2022 [cited 2022 Dec 2];24:106-13. Available from: https://www.sjohns.org/text.asp?2022/24/3/106/357633
| Introduction|| |
On March 11th, 2020, the World Health Organization declared coronavirus disease 2019 (COVID-19) to be a pandemic. With more than 10 million confirmed cases worldwide as of July 30, 2020, and a million deaths globally, this disease continued to grow exponentially. The main preventive measures are vaccination and social distancing, which aim to implement “methods for reducing the frequency and closeness of contact between people to decrease the risk of transmission of disease,” as described by the Center for Disease Control and Prevention. Several international and national organizations have recommended postponing nonurgent medical care including clinic visits and even elective surgeries.
Globally, numerous countries have applied nationwide lockdowns and restricted transportation between cities. The cochlear implanted patients were faced with difficult circumferences due to their need for highly specialized care providers.
This situation has led to increasing demand for telemedicine. Telemedicine is defined by the American Speech-Language-Hearing Association as “the application of technology to deliver health services at a distance.” The application of telemedicine started as early as the 1990s in Ear, Nose, and Throat practice. In 2008, confidence interval (CI) programming using telemedicine was re-introduced.
Previous studies have shown no significant differences in programming levels between in-office and remote programming (RP).,,,,
This study aims to evaluate the feasibility and stakeholders' satisfaction with RP of cochlear implants and to compare the audiological and speech outcomes during RP to the local programming sessions.
| Materials and Methods|| |
A prospective study was performed on patients who underwent cochlear implantation in a tertiary referral ear center. This study was conducted in accordance with the ethical standards of Helsinki Declaration revision 2013 and was approved by the institutional review board of the University Hospital with Reference Number 20/0627.
Recruited CI recipients included unilaterally or bilaterally implanted individuals who received implantation at our tertiary care center and agreed to participate. There were no age or gender restrictions for inclusion. Patients included have not reached a steady state and required follow-up and programming.
The recruited CI recipients were chosen with CI devices from one manufacturer in an attempt to standardize the software and evaluation parameters.
Patients were excluded if they had any disability other than hearing loss. Patients diagnosed with auditory neuropathy spectrum disorder and congenital inner ear anomalies were also excluded due to their special needs that may elongate the session or affect their outcomes.
The local host (LH) was a clinician, audiologist, or CI engineer. Any LH must be trained on how to conduct an RP session, be familiar with the software, and know basic troubleshooting.
The remote expert (RE) was a skilled audiologist from the primary managing center, with expertise in CI hearing evaluation and programming. Any RE must be trained on how to conduct an RP session, be familiar with the software, and know basic troubleshooting. RE has access to the individual patient's data in the primary managing center.
The video recording of the RE was not usually needed and was not regularly recommended, since it would have increased the need for internet bandwidth. However, it was deemed essential to have a webcam for the RE to be used when needed.
Setting and equipment
Extreme care was taken to provide remote sessions in a quiet environment; however, the rooms were not sound-treated.
Two computers were needed to perform the RP, one in the RE location and the other in the LH. Both these computers had microphones, speakers, and cameras and were connected to the internet. The speech processor of the patient was connected to the computer in the LH location via an interface cable and an interface. As a backup, a different internet connection was also available on standby, in case the connection was lost. Backup computers and cable connections were also available in both RE and LH locations. A standard telephone connection was made available in case both internet connections were disconnected.
The local and remote locations were connected via a hosted web service using a 128-bit advanced encryption standard that allowed sharing of the programming software as well as audiovisual communication. This hosted web service has a security system that requires authentication before use [Figure 1].
When patients arrive at the LH clinic, the LH introduces himself and explains how the session will be held. First, the LH checks the speech processor microphone's functioning and performed a fidelity check. The LH then starts a hosted web session, through which the programming software is shared, and invites the RE via a video call. which is the software used for audio communication. After the connection is established, the RE starts the session. MAESTRO 9 software was used for programming. The shared programming software enabled the RE to evaluate the patient and create a new program. The RP session was carried out in the same manner as in-person local sessions except that the clinician communicates and interacts with the patients and their families through a web service. At the beginning of each session, the RE establishes a connection with the patient and/or their caregiver, checking the audio and internet connection quality. Programming was performed based on the subjective perception and behavioral responses of the patients.
At the end of the session, the new program was downloaded to the patients' sound processor by the RE.
In each session, a new mapping is made. The RE actively monitors the software, hardware, and internet connection throughout the session, to avoid any data misinterpretation due to a problem in any of the previously mentioned. After the initial setup and illustrating the process to the patients and their companions, the LH waits outside the room to decrease the aerosol exposure duration to the patients and is called by the patient to come inside the room when needed.
In cases where the RE needed to visualize the patients' faces, the LH left the room to distance themselves from the possibility of aerosol exposure.
Only one companion was permitted to attend the session, and only if required, such as with pediatric patients.
The patients, companions, and LH would go through a screening area upon entering the remote clinic. Their temperature was measured, and they were asked for any recent history of contact with a known COVID-19 case or any history of signs and symptoms suggesting COVID-19. Anyone with any suspicious sign or symptoms were sent to primary health care for screening.
At the end of each session, the LH would sanitize the clinic environment and all equipment.
The quality of the session and the satisfaction of the patient and the RE and the LH were evaluated by three separate questionnaires. The patients' version of the questionnaire contains 7 items in the Arabic language. The patients or caregivers of the pediatric patients were given the questionnaire at the end of the session. The RE and LH versions of the questionnaire contained 16 items and 13 items, respectively, in the English language [Supplementary File 1] and [Supplementary File 2].
In case of multiple sessions for the same patient, new questionnaires were filled per session.
Other outcome measures
To confirm the feasibility of the remote session and to make sure that was not compromising the patients' performance, an audiological evaluation was performed in the next local session before programming. This evaluation included pure tone average (PTA) for frequencies 500 Hz, 1 kHz, 2 kHz, and 4 kHz, speech reception thresholds (SRT), and Word Recognition Score (WRS) in quiet using live voice, and it was compared with the audiologic findings of the same local session after programming and to the audiological findings of the session preceding the remote session. SRT was measured using the Arabic spondee list and WRS s were measured using the Arabic monosyllabic word lists. Each test session used a different monosyllabic word and a list of words. The tests were carried out in a quiet environment at 65 decibels hearing level. The American Speech-Language-Hearing Association recommendations were followed for all audiologic measurements.
Duration of each session
The duration (in minutes) from the time of the patient's entrance to the end of the session was recorded by the LH. This duration included any delay in the establishment of the internet connection or programming software issues. The duration of answering the questionnaire was not included. The duration of the remote session was compared with the duration of the next local session. Since it is not a routine of our practice to record the duration of each session, the duration of the session preceding the remote session was not available for comparison.
Frame rate and overall bandwidth
Video frame rate, measured in frames per second (fps), and overall bandwidth, measured in kilobits per second (kbit/s), are units for measuring the speed of digital information transferred through the internet connection. A minimum of 8 fps, 160 kbit/s for upload and 60 kbit/s for download, was set primarily to be an adequate internet connection.
The CI sound processor features a data logging system that enables an objective tool to monitor the daily duration of CI use in different acoustic environments. The finding of this data logging can partially predict the speech outcomes of the CI., Duration of CI used by data logging was collected during the RP session and the next local session.
Data were collected and managed in Excel software Version 16.37 (Microsoft Corporation 2020). Data were analyzed using the Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, USA) version 23. Statistical significance, CI, and study power were set at P < 0.05, 95%, and 80%, respectively. The data were found not to be normally distributed, so nonparametric statistics were used.
| Results|| |
This study included 22 RP sessions performed for 15 patients between June 4, 2020, and December 5, 2020. Most of the patients, 13 (86%) were children (below 18 years) and only two patients were adults who were 24 and 71 years old. For the pediatric group, the age ranged from 1 to 13 years of age [Table 1].
Six LHs and 4 REs participated in this study. The duration of each session in the RP sessions lasted from 17 to 96 min with a mean of 36.2 ± 18.3 min. While the duration of the local session after the RP session lasted from 13 to 67 min with a mean of 32.2 ± 11.0. Using the Wilcoxon test, there was no statistically significant difference between the RP and local sessions (mean difference 2.8 min, P = 0.29).
The LHs', REs', and patients/families' satisfaction was generally high, Their satisfaction was all above or equal to 6/10, 5/10, and 7/10 on a Likert scale, respectively (with 10 being the most satisfied). All LHs, REs, and 93% of the patients/family would use RP if they opted to and all of them would recommend RP to others [Figure 2], [Figure 3] and [Supplementary File 3].
The REs were also asked about the role of the LH in the data shown in [Figure 4].
|Figure 4: Opinion of the remote expert on the role of the local host in the remote programming sessions|
Click here to view
None of the LHs in contact with the patients developed COVID-19 nor did any of the patients within 14 days of the RP sessions. No adverse effects were seen in RP sessions. Another case of facial nerve stimulation was managed by increasing the pulse width locally for individual electrodes and remeasuring threshold (THR) and maximum most comfortable level (MCL) for all electrodes.
There was no significant difference in the audiological parameters, including PTA, SRT, and WRS when comparing the session preceding the RP, the results of the RP session, and the session after the RP (Wilcoxon test, P value ranging from 0.06 to 0.73) [Table 2].
|Table 2: Comparing the audiological and programming parameters of the local and remote sessions|
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Evaluation of the programming parameters showed no difference in the THR in the three sessions. While the MCL was higher, and the impedance was lower in the RP session compared to the local session preceding and the RP [Table 2].
Data logging showed a higher duration of speech processor usage, with a mean difference of 0.64 h/day, recorded in the local programming post-RP sessions compared to the RP session (Wilcoxon, P = 0.006). It must be noted that the data logging obtained during the RP session is representing the duration of CI use before the RP and is an outcome of the programming done in the local session preceding the remote session. While the data logging of the next local session is representing the duration of CI use after the RP and is the outcome of the remote session. The CI hearing age does not correlate with the audiological and programming parameters (Pearson correlation from 0.006 to 0.29 with P > 0.2) [Figure 5].
|Figure 5: Correlation matrix between the CI hearing age and audiological and programming parameters, CI: Confidence interval|
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| Discussion|| |
Using telemedicine has numerous advantages during the pandemic era. It can reduce the patients' traffic in the COVID-19 hosting hospitals and decrease the need for the use of public transportation by patients. This method also would distribute a load of patients from attending one central tertiary center in one facility to numerous clinics widespread in the country closer to the patients' residency. One particular benefit of telemedicine in CI practice is that it enables the practitioner and the patient to see each other's faces without a mask. This is important because the CI clinics deal with hard of hearing/deaf patients that may depend on lip reading. Additionally, in a programming session, it is of utmost importance for the audiologist to visualize the patients' minor facial expressions without a face mask, particularly in young children, to detect any discomfort or facial nerve stimulation. During programming sessions, lip reading can be vital to communicate with CI recipients while their devices are not in live mode. CI care provision also includes speech-language rehabilitation sessions which can necessitate the use of visual cues and lip reading which demands that clinicians have managed to show their faces.
In this study, we illustrated the setting for RP adjusted to the special situation of COVID-19 pandemic. This study aimed to evaluate the feasibility and satisfaction with RP settings. Like previous studies, our data show high levels of satisfaction and minimal problems with RP from all participating parties including patients, REs, and the LHs.,,,
The audiological evaluation of the patients in the local session next to the RP session showed no significant changes in the PTA, SRT, and WRS in comparison to the previous local session and the next local session. This demonstrates that there was no adverse effect on the performance when RP is used.
The programming parameters of the patients were different in the RP compared to the local sessions. However, due to the time difference between these sessions, similar programming parameters were not expected.
There was a large variation in the duration of CI experience among the included patients. Although this variation can affect the duration of each session and the audiologic and programming parameters of the patients, it can be a good indicator for generalization of how feasible the RP is. Patients showed that they could easily cope to the new setting of RP.
The feasibility of RP for young children is scarcely studied., This study confirms that RP is as feasible in young children as in adults. Difficult cases were successfully managed through RP. A patient with facial nerve stimulation successfully managed via RP by use of triphasic stimulation. This patient was also complaining of tinnitus preactivation which makes it difficult to obtain the appropriate programming parameters. Another case with pain during device use was managed with deactivation of one electrode.
Connection problems causing audio-visual interruptions and delays were not ignorable, however, these problems were brief and did not seriously affect the satisfaction of the users.
Previous studies have suggested that the LH does not need to be an audiologist. The current study illustrates that the role of the LH was mainly limited to the initial setup of the session and the patients could mostly complete the session alone. Providing public user-friendly software with a simpler setup or providing illustrative videos on how to use the current software can enable patient-centered programming in their homes shortly.
However, an alternative to the interface and cable connections will be needed. A wireless connection of the speech processor to the computer can solve this problem. Meanwhile, the current findings can suggest that a low level of qualification for the LH is needed. This finding can decrease the cost of RP sessions if the LHs are chosen with less qualification.
Another issue that was faced by the RP was the size of the video screen, which covered some parts of the programming software and necessitated moving the video screen across the desktop screen or minimizing the size of the video screen. It might be suggested that the video feed of the patient would have a separate screen to maintain the video connection throughout the session. Another issue that needs to be addressed is the fact that the programming screen should not be displayed on the patients' screen during programming, to avoid false positive reactions when measuring THR levels. For the pediatric population, it was imperative that a caregiver was with them to reinstruct them or use their own toys (they would bring with them) for stimulus-response.
The nonmedical cost for each hospital visit in our center has been reported to range from 81 to 748 USD for patients who do not live in the same city. This recurring cost can be put into a one-time purchase of the connection interface. Furthermore, developing wireless connection software from the speech processor to the computer can eliminate the need for cables and the connection interface in the future.
There is a scarcity of providers of specialized hearing healthcare with an increasing demand for this service due to the increased number of implanted patients. During the COVID-19 era, recurrent national lockdowns have led to the inability of patients to reach care providers. RP can help easily connect patients in areas that lack specialized care centers to care providers at a central specialized center.
Implementing social distancing was much easier with RP settings. To decrease the exposure time, the LH would prepare the setup before the arrival of each patient. The exposure of the LH to the patient was limited to when any help or troubleshooting was needed. The good satisfaction level with RP from all parties suggests that this method can be used even in normal situations, outside the circumstances of COVID-19 outbreak. It can be particularly beneficial for patients living far from specialized ear centers.
| Conclusion|| |
Remote Programming is a promising field in cochlear implant rehabilitation. The findings of this study showed the feasibility of RP, which was found to be particularly beneficial during the pandemic era. Furthermore, difficult cases can be managed through RP by an experienced RE.
This article is of the recommended ideas for research projects by Saudi ORL.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| Supplementary Files|| |
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2]