Design Improvements With SONNET 3

MED-EL

Status

Enrolling

Conditions

Hearing Loss, Sensorineural

Treatments

Device: Audio processor

Study type

Interventional

Funder types

Industry

Identifiers

NCT06597747

G240188

Details and patient eligibility

About

Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.

Full description

This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.

Enrollment

20 estimated patients

Sex

All

Ages

7+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Implanted with a MED-EL cochlear implant in at least one ear
≥ 12 months since activation of the MED-EL audio processor
Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor
Ability to complete all study procedures
Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study

Exclusion criteria

Evidence that hearing loss is retrocochlear in origin
Unable to provide reliable feedback during cochlear implant programming
Skin or scalp condition precluding use of the study device
Unrealistic participant or parent (if applicable) motivation or expectations
Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.