Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit

Sponsor
Sonova AG
Study ID
NCT07414329
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rechargeable behind-the-ear hearing device kit — DEVICE
    This intervention includes the following components: hearing aid, charger, applicable accessories

Study Details

The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are: * Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while providing a satisfactory user experience? * Does the rechargeable behind-the-ear hearing device kit improve speech understanding in noise in a lab setting? Researchers will compare participants' performance with the rechargeable behind-the-ear hearing device kit to the unaided condition to see if it works to treat hearing loss. The rechargeable behind-the-ear hearing device kit will be subjectively compared to their personal hearing device experience. Participants will: * Use the rechargeable behind-the-ear hearing device kit for approximately 2 weeks. * Visit the clinic for the initial fitting and follow-up testing at the end of the study. Additional study visits may take place, as needed. * Complete questionnaires to identify challenging listening situations and provide feedback on their experience with the devices. * Complete lab testing to assess speech intelligibility in the presence of background noise and provide subjective feedback on features in the Mobile application.

Key Dates

First listed
Feb 17, 2026
Start date
Jan 30, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2026
Completion
Apr 15, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hearing device kit users
    Participants will use the rechargeable behind-the-ear hearing device kit for the duration of their study participation in the lab and during their take home trial.

Primary Outcome Measure

Subjective questionnaire feedback [ Time Frame: From enrollment to the end of treatment at 2 weeks ]

Central Contacts

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