Evaluation of Flexible Conductive Hearing Aids
ConditionConductive Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-80
SponsorWake Forest University Health Sciences
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Adult patients unable to independently understand the purpose of the study and the procedures and/or who are not willing to participate
Trial design
Design model
Single group
Treatments tested in this trial
flexible conductive hearing aid
DeviceEligible 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: flexible Band-Aid style hearing deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 1Sponsors and contacts
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Source ClinicalTrials.gov