Evaluation of Flexible Conductive Hearing Aids

Wake Forest University Health Sciences200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

200

Conditions

Conductive Hearing Loss

Interventions

flexible conductive hearing aidDEVICE

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Does the subject indicate hearing or states they can hear sound

Voltage (with a maximum of 20 V, frequency range: 20 Hz to 20 kHz) will be applied to Micro epidermal actuator (MEA) through external power supply/function generator, or through amplifier in the hearing aid circuit. While wearing the device, they are asked to respond or repeat when they hear sound either delivered through the device or through the speaker on the wall in front of them. All sounds are presented at a comfortable level.

Time frame: Hour 1

Central Contacts

Mohammad Moghimi, PhD

CONTACT

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

Enosh Lim, MS

CONTACT

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

Data from ClinicalTrials.gov

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