Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rechargeable behind-the-ear hearing device kit.
- Who it may be relevant to
- Registry conditions: Hearing Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025
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.
Interventions
- Device Rechargeable behind-the-ear hearing device kit
This intervention includes the following components: hearing aid, charger, applicable accessories
Primary outcome measures
- Subjective questionnaire feedback [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (1)
- Hearing in Noise Test (HINT) [Time frame: At the end of treatment, after two weeks of device use.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- National Hearing Services Inc — Kitchener
- National Hearing Services Inc — Mississauga
Identifiers
NCT: NCT07414329 · SRF-33501 · 401131