Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07222202

Conditions

Conductive Hearing Loss

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

flexible conductive hearing aid

Study Details

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

Study ID

NCT07222202

Start date

Jan 14, 2026

Status verified date

Oct, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mohammad Moghimi, PhD

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

Enosh Lim, MS

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

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Mohammad Moghimi, PhD

336-713-2113Seyyed.moghimi@wfusm.edu

Enosh Lim, MS

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

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jan 27, 2026

Last verified

Oct, 2025

Keywords

  • hearing aids
  • hearing loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-01-27.