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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software
University of Kansas Medical Center
Kansas City, Kansas, United States
University of North Carolina
Chapel Hill, North Carolina, United States
MED-EL Corporation
Durham, North Carolina, United States
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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