Evaluation of Flexible Conductive Hearing Aids

Conditions

• Conductive Hearing Loss

Eligibility Criteria

Sex

ALL

Age

6 Months - 80 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Jan 14, 2026

Status verified

Oct 2025

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: flexible Band-Aid style hearing device
  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.

Primary Outcome Measure

Does the subject indicate hearing or states they can hear sound [ Time Frame: Hour 1 ]

Central Contacts

• Mohammad Moghimi, PhD
  (336) 713-2113
  [email protected]
• Enosh Lim, MS
  704-355-2000
  [email protected]

Locations (1)

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