Design Improvements With SONNET 3

Last updated: March 24, 2025
Sponsor: Med-El Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Deafness

Treatment

Audio processor

Clinical Study ID

NCT06597747
G240188
  • Ages > 7
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 studyprocedures for the duration of the study

Exclusion

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 inhearing, global health status, etc.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Audio processor
Phase:
Study Start date:
December 16, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • University of North Carolina

    Chapel Hill, North Carolina 27517
    United States

    Active - Recruiting

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