NCT07222202

Evaluation of Flexible Conductive Hearing Aids

A Noninvasive, Flexible Conductive Hearing Aid With Micro-epidermal Actuators on Pediatric and Adult Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 6 Months – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

Standard treatment for permanent conductive hearing loss includes osseointegrated implants, which require surgery and are invasive for pediatric patients. Conductive hearing loss can also be treated by non-surgical solutions such as wearable and behind-the-ear aids; however, they present challenges such as instability, stigmatization, and discomfort because of the device's design. Therefore, patients (ages 6 months to 80 years) with permanent (CHL) can benefit from a flexible, Band-Aid like hearing aid.

Conditions

• Conductive Hearing Loss

Interventions

Type	Name	Description
DEVICE	flexible conductive hearing aid	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.

Timeline

• Start date: 2026-01-14
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-10-29
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study