Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

MED-EL

Status: Invitation-only

Conditions: Cochlear Implants; Asymmetric Hearing Loss; Single-Sided Deafness (SSD); Hearing Loss, Sensorineural; Hearing Loss, Unilateral

Treatments: Device: Programming of cochlear implant audio processor frequency settings

Study type: Interventional

Funder types: Industry

Identifiers

NCT06734039

US2401 MED-EL ABF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 4 patient groups

Default Clinical Frequency Setting

Active Comparator group

Description:

The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software

Treatment:

Device: Programming of cochlear implant audio processor frequency settings

Default Anatomy-Based Fitting

Active Comparator group

Description:

The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software

Treatment:

Device: Programming of cochlear implant audio processor frequency settings

Experimental Anatomy-Based Fitting 1

Experimental group

Description:

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.

Treatment:

Device: Programming of cochlear implant audio processor frequency settings

Experimental Anatomy-Based Fitting 2

Experimental group

Description:

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.

Treatment:

Device: Programming of cochlear implant audio processor frequency settings