An interventional study of Programming of cochlear implant audio processor frequency settings in Hearing Loss, Unilateral, Cochlear Implants and Hearing Loss, Sensorineural, sponsored by Med-El Corporation. Enrolling by invitation at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Med-El Corporation · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.
Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.
51 studies on the registry are indexed under Hearing Loss, Unilateral; 7 are open to participants now.
This study's planned enrollment of 50 is above the median of 35 across 35 interventional studies indexed under Hearing Loss, Unilateral.
Browse Hearing Loss, Unilateral studies →Med-El Corporation is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software
Device: Programming of cochlear implant audio processor frequency settings
The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software
Device: Programming of cochlear implant audio processor frequency settings
The audio processor frequency setting will be programmed using experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.
Device: Programming of cochlear implant audio processor frequency settings
The audio processor frequency setting will be programmed with experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.
Device: Programming of cochlear implant audio processor frequency settings
Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software
Also known as: anatomy-based fitting
Percent correct on AzBio Sentences in Noise
The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).
Time frame: 3 to 7 months
Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)
Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.
Time frame: Enrollment to 7 months
Post-operative Audiogram
Unaided pure-tone audiometric thresholds will be tested for both ears. For patients with moderate to moderately severe hearing loss in the unimplanted ear, thresholds will also be tested in the best-aided condition.
Time frame: Enrollment and 12 months
Percent Correct on Az Bio Sentences in Noise
The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).
Time frame: 12 months
Percent Correct on Consonant Nucleus Consonant (CNC) Words
The CNC test, consisting of 50 words scored as percent correct, will be tested in quiet after listening experience with each frequency setting for the implanted ear alone.
Time frame: 3 to 12 months
Subjective feedback questionnaire
Subjects will complete a non-validated subjective questionnaire assessing their perceptual sound quality prior to and after listening experience with different frequency settings. The questionnaire utilizes multiple choice questions, a 5-point Likert scale, and open-ended questions intended to collect subject feedback.
Time frame: Enrollment to 12 months
Psychoacoustic Testing of Sound Quality and Preference
Subjects will listen to speech and non-speech sounds will rate the quality of each sound on a 6-point Likert scale using different frequency settings. Subjects will then be asked to rank the different frequency settings relative to each other for quality and preference.
Time frame: 7 months
Cochlear Implant Quality of Life- 35 Profile (CIQoL35)
Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.
Time frame: 12 months
Decisional Regret Scale
A validated questionnaire using a 5-point Likert scale to assess decisional regret after cochlear implantation.
Time frame: 3 to 12 months
Started Nov 2025 (actual). Primary completion is estimated for Apr 2028, 29 months after the start.
Of 24 interventional studies with no phase under Hearing Loss, Unilateral, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 83. This study's planned 29 months is below that.
How these figures are worked out, and which studies are left out of them.
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