Evaluation of Flexible Conductive Hearing Aids

NCT07222202 | Recruiting FDA Device

• 1 other identifier: IRB00133858
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Conductive hearing loss (CHL) is the most common type of hearing loss among the pediatric population. CHL occurs when sound is not properly transmitted from the external ear to the cochlea, and congenital pathologies like microtia/anotia, atresia, and absent or malformed ossicles make hearing loss permanent.

Conditions

Conductive Hearing Loss

Keywords

hearing aids; hearing loss

Outcome Measures

Primary Outcomes (1)

• Does the subject indicate hearing or states they can hear sound

  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.

  Hour 1

Study Arms (1)

flexible Band-Aid style hearing device

EXPERIMENTAL

Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold before using the hearing aid and reassessed with our hearing aid attached. Healthy subjects will wear noise-cancelling headphones and ear plugs to simulate conductive hearing loss, and their hearing threshold will be assessed before and during the flexible hearing aid attachment.

Device: flexible conductive hearing aid

Interventions

flexible conductive hearing aid DEVICE

Eligible patients will wear hearing aids on flexible substrate and MEA (Micro epidermal actuator is a flexible material (e.g., plastics) to be placed on epidermis layer of skin for generating vibrations) on skull behind the ear or forehead. A neonatal adhesive, tape, Band-Aid or a headband will secure the aid/MEA on the skin.

flexible Band-Aid style hearing device

Eligibility Criteria

• Age: 6 Months - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Moghimi, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Moghimi, PhD

CONTACT

(336) 713-2113; Seyyed.moghimi@wfusm.edu

Enosh Lim, MS

CONTACT

704-355-2000; Enosh.Lim@wfusm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold before using the hearing aid and reassessed with our hearing aid attached. Healthy subjects will wear noise-cancelling headphones and ear plugs to simulate conductive hearing loss, and their hearing threshold will be assessed before and during the flexible hearing aid attachment.

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 29, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately after publication. No end date
• Access Criteria: Any purposes

Locations

US (1)