BridgeMD
Tests treatment safety and results for Hearing Loss
Official title Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
ClinicalTrials.gov ID: NCT07414329
What this study is testing
- What it's testing
- 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?
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Good understanding (read/write/speak) of the English language.
You likely can't join if
- Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study...
- 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).
See the full eligibility 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Kitchener, Ontario, Canada
- Mississauga, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kitchener, Ontario, Canada; Mississauga, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.