Evaluation of Flexible Conductive Hearing Aids
A Noninvasive, Flexible Conductive Hearing Aid With Micro-epidermal Actuators on Pediatric and Adult Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammad Moghimi, PhD
- Phone Number: (336) 713-2113
- Email: Seyyed.moghimi@wfusm.edu
Study Contact Backup
- Name: Enosh Lim, MS
- Phone Number: 704-355-2000
- Email: Enosh.Lim@wfusm.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Enosh Lim, MS
- Phone Number: 704-355-2000
- Email: Enosh.Lim@wfusm.edu
-
Contact:
- Mohammad Moghimi, PhD
- Phone Number: 336-713-2113
- Email: Seyyed.moghimi@wfusm.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Does the subject indicate hearing or states they can hear sound
Time Frame: 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. |
Hour 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mohammad Moghimi, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00133858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
All of the individual participants data, collected during the trial after deidentification
IPD Sharing Time Frame
Immediately after publication. No end date
IPD Sharing Access Criteria
Any purposes
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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