Flexible bandage-style conductive hearing aid for conductive hearing loss
A Noninvasive, Flexible Conductive Hearing Aid With Micro-epidermal Actuators on Pediatric and Adult Patients
NA · Wake Forest University Health Sciences · NCT07222202
This study will test a flexible, Band-Aid–like conductive hearing aid for children and adults with permanent conductive or mixed hearing loss to see if it improves comfort and hearing without surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 6 Months to 80 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT07222202 on ClinicalTrials.gov |
What this trial studies
This interventional study tests a flexible, bandage-style conductive hearing aid as a non-surgical option for patients with permanent conductive or mixed hearing loss aged from about 6 months to 80 years. Participants will include patients seen at the study site with unilateral or bilateral conductive or mixed hearing loss as well as healthy volunteers, and the device will be fitted and worn to measure comfort, stability, and hearing function. The trial is intended to address drawbacks of osseointegrated implants (which require surgery) and conventional behind-the-ear aids (which can be unstable or stigmatizing). Procedures include device fitting and in-person follow-up visits at the trial site to collect objective hearing measures and patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates are infants, children, adolescents, and adults (approximately 6 months to 80 years) with unilateral or bilateral permanent conductive or mixed hearing loss who are candidates for conductive hearing aids or related middle-ear surgery.
Not a fit: People whose hearing loss is primarily sensorineural (inner-ear) rather than conductive, or adults who cannot give informed consent, are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could offer a comfortable, non-surgical alternative that improves hearing, wearability, and social comfort for people with conductive hearing loss.
How similar studies have performed: Surgical osseointegrated implants and conventional hearing aids are established treatments for conductive loss, but a flexible Band-Aid–style conductive hearing aid is a more novel approach with limited prior published data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female infants, children, adolescents, and adult patients who are diagnosed with unilateral or bilateral mixed or conductive hearing loss * Male and female patients seen at Atrium Health-Audiology for a clinical, standard of care office visit who have a diagnosis of conductive or mixed hearing loss and may currently wear hearing aids * Male and female infants, children, adolescents, and adults who are candidates for conductive hearing aids (Osseo-integrated or wearable aids) or for canalplasty or ossicular chain reconstruction surgery * Healthy subjects will include male and female infants, children, adolescents, and adults who do not have conductive or mixed hearing loss * Pregnant women -are eligible for this study. Standard of Care allows pregnant patients to be fit for hearing aids without risk. Exclusion Criteria: * Adult patients unable to independently understand the purpose of the study and the procedures and/or who are not willing to participate
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Mohammad Moghimi, PhD — Wake Forest University Health Sciences
- Study coordinator: Mohammad Moghimi, PhD
- Email: Seyyed.moghimi@wfusm.edu
- Phone: (336) 713-2113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Conductive Hearing Loss, hearing aids, hearing loss