Flexible bandage-style conductive hearing aid for conductive hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.