Clinical trial NCT06734039: Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
Official title: Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hearing Loss, Unilateral
Cochlear Implants
Hearing Loss, Sensorineural
Single-Sided Deafness (SSD)
Asymmetric Hearing Loss
Keywords: cochlear implant
Single-Sided Deafness
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2024-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percent correct on AzBio Sentences in Noise
timeFrame: 3 to 7 months
measure: Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)
timeFrame: Enrollment to 7 months
Secondary outcomes:
measure: Post-operative Audiogram
timeFrame: Enrollment and 12 months
measure: Percent Correct on Az Bio Sentences in Noise
timeFrame: 12 months
measure: Percent Correct on Consonant Nucleus Consonant (CNC) Words
timeFrame: 3 to 12 months
measure: Subjective feedback questionnaire
timeFrame: Enrollment to 12 months
measure: Psychoacoustic Testing of Sound Quality and Preference
timeFrame: 7 months
measure: Cochlear Implant Quality of Life- 35 Profile (CIQoL35)
timeFrame: 12 months
measure: Decisional Regret Scale
timeFrame: 3 to 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: MED-EL Corporation
state: North Carolina
Study officials:
References:
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