NCT07414329

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

Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Hearing Loss

Interventions

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

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-03-31
• Completion: 2026-04-15
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

2 sites across 1 country: Canada