Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07414329

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

Led by Sonova AG · Updated on 2026-02-17

20

Participants Needed

2

Research Sites

10 weeks

Total Duration

On this page

Sponsors

S

Sonova AG

Lead Sponsor

N

National Hearing Services Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Current and experienced hearing aid users actively using hearing aids for at least 3 months
  • Audiograms fitting the device's range: mild to profound bilateral hearing loss
  • Ability to consent, operate the device controls, and follow study directions
  • Good understanding of English (read, write, speak)
  • Willingness to wear binaural behind-the-ear investigational devices for 6-8 hours daily
  • Good overall health including healthy outer ears without excessive wax or debris
  • Ear canal size and shape suitable for proper device fitting
  • Socially active participants frequently encountering noisy situations
  • Ownership and use of a smartphone for pairing with hearing aids
  • Representative of typical hearing instrument users in age and hearing loss
Not Eligible

You will not qualify if you...

  • Significant medical conditions likely to interfere with study procedures or confound results
  • Known allergy or hypersensitivity to the investigational device or its components
  • Limited ability to describe hearing experiences or use of hearing aids
  • Acute tinnitus less than three months since onset
  • Inability to attend scheduled study visits due to mobility or scheduling issues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

National Hearing Services Inc

Kitchener, Ontario, Canada, N2E 1Y6

Actively Recruiting

2

National Hearing Services Inc

Mississauga, Ontario, Canada, L5L1J3

Actively Recruiting

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Research Team

S

Study Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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