Asymmetric Hearing Loss, Cochlear Implants, Hearing Loss, Sensorineural, Hearing Loss, Unilateral, Single-Sided Deafness (SSD)
Conditions
Keywords
cochlear implant, Single-Sided Deafness
Brief summary
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.
Detailed description
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.
Interventions
DEVICEProgramming of cochlear implant audio processor frequency settings
Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software
Sponsors
Med-El Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to each of the frequency settings they are utilizing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Is a cochlear implant candidate as deemed by the participating center * Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear. * For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment * Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear. * Programmed with electric-only stimulation in the implanted ear * The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz * Post-operative CT scan allows for completion of OTOPLAN analysis * ABF settings possible at defaults in clinical programming software * Minimum of 10 active electrodes at activation * Programmed using a Fine Structure coding strategy * English is the primary language * Willing and able to comply with all scheduled procedures as defined in the protocol
Exclusion criteria
* Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study * Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use * Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent correct on AzBio Sentences in Noise | 3 to 7 months | 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 (%). |
| Cochlear Implant Quality of Life - 35 Profile (CIQoL 35) | Enrollment to 7 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Audiogram | Enrollment and 12 months | 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. |
| Percent Correct on Az Bio Sentences in Noise | 12 months | 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 (%). |
| Percent Correct on Consonant Nucleus Consonant (CNC) Words | 3 to 12 months | 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. |
| Subjective feedback questionnaire | Enrollment to 12 months | 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. |
| Psychoacoustic Testing of Sound Quality and Preference | 7 months | 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. |
| Cochlear Implant Quality of Life- 35 Profile (CIQoL35) | 12 months | 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. |
| Decisional Regret Scale | 3 to 12 months | A validated questionnaire using a 5-point Likert scale to assess decisional regret after cochlear implantation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatelyn Glassman, AuD
Med-El Corporation
Outcome results
None listed