Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

Study Overview
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Brief Summary
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Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting map is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. This study will focus on patients that are already implanted with the HEARO robotic system.

Official Title
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Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

Conditions
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Cochlear Implants, Sensorineural Hearing Loss, Bilateral

Intervention / Treatment
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* Device: Post-operative ABF followed by fitting according to clinical standard
* Device: Fitting according to clinical standard followed by post-operative ABF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s) Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS) Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid) Pre- operative and post-operative CT scan of the temporal bone available Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available Audio processor not yet activated on the newly implanted side Minimum of 10 active channels can be activated Fluent in the language of the test centre (Dutch or French) Signed and dated ICF before the start of any study-specific procedure Exclusion Criteria: Subject is a Single-Sided Deafness (SSD) CI user Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor) Lack of compliance with any inclusion criteria Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABF fitting followed by standard fitting<br> | Device: Post-operative ABF followed by fitting according to clinical standard<br>* Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months.<br>|
| Active Comparator: Standard fitting followed by ABF fitting<br> | Device: Fitting according to clinical standard followed by post-operative ABF<br>* Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR |  | 3 months post- activation | 
| Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR |  | 6 months post- activation | 
| Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR |  | 8 months post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech recognition in quiet: Percentage correctly identified phonemes |  | 3 months post-activation | 
| Speech recognition in quiet: Percentage correctly identified phonemes |  | 6 months post-activation | 
| Speech recognition in quiet: Percentage correctly identified phonemes |  | 8 months post-activation | 
| Speech discrimination: Number of correctly discriminated pairs of phonemes |  | 3 months post- activation | 
| Speech discrimination: Number of correctly discriminated pairs of phonemes |  | 6 months post- activation | 
| Speech discrimination: Number of correctly discriminated pairs of phonemes |  | 8 months post- activation | 
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) |  | 1 month post- activation | 
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) |  | 3 month post- activation | 
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) |  | 6 months post- activation | 
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) |  | 8 months post- activation | 
| Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from Never to Always (Statement 1-55) or from No to Quite well (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome. | Baseline at activation | 
| Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from Never to Always (Statement 1-55) or from No to Quite well (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome. | 3 months post- activation | 
| Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from Never to Always (Statement 1-55) or from No to Quite well (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome. | 6 months post- activation | 
| Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from Never to Always (Statement 1-55) or from No to Quite well (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items. For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome. | 8 months post- activation | 
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain | The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome. | Baseline at activation | 
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain | The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome. | 3 months post- activation | 
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain | The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome. | 6 months post- activation | 
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain | The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome. | 8 months post- activation | 
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit | The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option not applicable correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit. | Baseline at activation | 
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit | The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option not applicable correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit. | 3 months post- activation | 
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit | The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option not applicable correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit. | 6 months post- activation | 
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit | The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option not applicable correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit. | 8 months post- activation |