Evaluation of Flexible Conductive Hearing Aids

Wake Forest University (WFU)

Status: Begins enrollment this month

Conditions: Conductive Hearing Loss

Treatments: Device: flexible conductive hearing aid

Study type: Interventional

Funder types: Other

Identifiers

NCT07222202

IRB00133858

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 months to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

flexible Band-Aid style hearing device

Experimental group

Description:

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.

Treatment:

Device: flexible conductive hearing aid