Conductive Hearing Loss
Conditions
Keywords
hearing aids, hearing loss
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.
Detailed 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.
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Does the subject indicate hearing or states they can hear sound | Hour 1 | 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. |
Countries
United States
Contacts
CONTACTMohammad Moghimi, PhD
CONTACTEnosh Lim, MS
PRINCIPAL_INVESTIGATORMohammad Moghimi, PhD
Wake Forest University Health Sciences
Outcome results
None listed