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Flexible Conductive Hearing Aids for Hearing Loss

This study is testing a new type of hearing aid called a flexible conductive hearing aid. This device uses a flexible material (like plastic) placed on the skin behind your ear or on your forehead to create vibrations that help you hear. It's designed to be a less invasive option than surgery for people with conductive hearing loss (when sound doesn't travel well to the inner ear). We are looking for 200 participants, from 6 months to 80 years old, who have been diagnosed with conductive or mixed hearing loss. The main goal is to see if you can hear sounds with this new hearing aid, measured within the first hour of use. The current status of recruitment is unclear.

Study design
This is an interventional study planning to enroll 200 participants. It is not specified if it is randomized or blinded.
What's involved
Eligible patients will wear the flexible conductive hearing aids and a Micro epidermal actuator (MEA) on their skull behind the ear or forehead. The primary endpoint is measured at Hour 1.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Hour 1, so follow-up beyond that is not specified.

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NCT07222202

Evaluation of Flexible Conductive Hearing Aids

Recruiting
NAAges 6–80InterventionalBasic science
Wake Forest University Health Sciences
~200 participants
Updated 2026-01-27 on ClinicalTrials.gov
What's tested:flexible conductive hearing aid

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Does the subject indicate hearing or states they can hear sound
Measured over Hour 1

Conditions

Conductive Hearing Loss

Explore related trials

Conductive Hearing LossHealthyMixed Hearing Loss

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Mohammad Moghimi, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Mohammad Moghimi, PhD
[email protected]
(336) 713-2113
Email the study team

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Eligibility criteria

Inclusion

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

Adult patients unable to independently understand the purpose of the study and the procedures and/or who are not willing to participate

What this trial measures

  • Does the subject indicate hearing or states they can hear soundHour 1

    Voltage (with a maximum of 20 V, frequency range: 20 Hz to 20 kHz) will be applied to Micro epidermal actuator (MEA) through external power supply/function generator, or through amplifier in the hearing aid circuit. While wearing the device, they are asked to respond or repeat when they hear sound either delivered through the device or through the speaker on the wall in front of them. All sounds are presented at a comfortable level.