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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • Adults (aged 18 years or older)
  • Current and experienced hearing aid users (actively using hearing aids for at least 3 months)
  • Audiograms that fit within the fitting range of the devices (mild to profound bilateral hearing loss)
  • Cognitive and functional capability to consent to study procedures, operate the controls for the devices and comply with all directions during the study.
  • Good understanding (read/write/speak) of the English language.
  • Willingness to comply with all study requirements including minimum wear-time (6-8 hrs/day) of binaural BTE(RIC) investigational devices.
  • Good overall health including healthy outer ear with no excessive wax/debris.
  • Ear canal size/shape must accommodate appropriate fitting of the hearing device.
  • Socially engaged participants are a top priority (out \& active socially) who frequently encounter the noisy situations in which the devices are meant to be used.
  • Use/ownership of a smartphone to pair hearing aids with for use with phone calls and streaming.
  • Otherwise, the study population is representative of typical hearing instrument users in age and presence of hearing loss

Exclusion Criteria:

  • Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study endpoint.
  • Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes.
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid.
  • Acute tinnitus (\<three months after onset).
  • Inability to attend scheduled visits (mobility and/or scheduling).

Study details
    Hearing Loss

NCT07414329

Sonova AG

14 May 2026

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