Status:
COMPLETED
Clinical Investigation and Validation of a Self-fitted Air-conduction Hearing Aid
Lead Sponsor:
Concha Inc.
Collaborating Sponsors:
University of Minnesota
San Jose State University
Conditions:
Hearing Loss
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Approximately 48 million people in the United States have hearing loss or hearing difficulties in noisy environments. Concha Inc. is working on introducing a wireless air-conduction hearing aid to the...
Detailed Description
The clinical study will be carried out using a within-subject, randomized, crossover study design in which all study participants will complete two different study arm conditions (clinician-fitting an...
Eligibility Criteria
Inclusion
- Adults, 18 years of age or older
- Apple iPhone X or newer (iOS 14 compatible or greater)
- Mix of male and female subjects
- Willing and able to perform all tests required for the study
- Signed and dated informed consent before the start of any study specific procedure
- Able to read and comprehend English
- Mild-to-moderate bilateral sensorineural hearing loss (defined according to thresholds from 250-8000 Hz with at least one threshold greater than 20 dB HL and thresholds at 500, 1000, 2000 and 4000 Hz less than or equal to 55, 65, 70, and 80 dB HL, respectively)
Exclusion
- Hearing outside of limits noted, above
- Visible deformities of the ear since birth or from injury
- Fluid, pus, or blood coming out of the ear within the previous six months
- Sudden, quickly worsening, or fluctuating hearing loss within the previous six months
- Dizziness or periodic vertigo associated with hearing loss
- Hearing loss in only one ear or a large difference in hearing between ears
- Ear wax build up or feeling that something is in the ear canal
- Pain or discomfort in the ear
- Inability to follow the procedures of the study due to language problems, or other cognitive problems
- Any other history of chronic middle and outer ear disease
Key Trial Info
Start Date :
January 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06167161
Start Date
January 30 2023
End Date
May 30 2023
Last Update
December 18 2023
Active Locations (2)
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1
San Jose State University
San Jose, California, United States, 95192
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455