RecruitingNot ApplicableNCT07222202

Evaluation of Flexible Conductive Hearing Aids

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


Sponsor

Wake Forest University Health Sciences

Enrollment

200 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 MonthsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria1

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

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Interventions

DEVICEflexible 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.


Locations(1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

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NCT07222202


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