Status:
NOT_YET_RECRUITING
Evaluation of Flexible Conductive Hearing Aids
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Conductive Hearing Loss
Eligibility:
All Genders
6-80 years
Phase:
NA
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 congen...
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 b...
Eligibility Criteria
Inclusion
- 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
- Adult patients unable to independently understand the purpose of the study and the procedures and/or who are not willing to participate
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07222202
Start Date
January 1 2026
End Date
November 1 2027
Last Update
November 24 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157