Status:
COMPLETED
Osia CPT Code Study
Lead Sponsor:
Cochlear
Conditions:
Conductive Hearing Loss
Mixed Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent.
- Proficient in English.
- Hearing loss etiology of Conductive or Mixed Conductive loss.
- Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the treatment ear.
- Aged 18 years and older.
Exclusion
- Unwilling to wear the treatment device or comply with the surgical and rehabilitation requirements of the study.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- Medical, audiological or psychological conditions, as judged by the investigator that might contraindicate participation in the clinical investigation.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
- Prior experience with a surgical bone conduction treatment option
- Insufficient bone quality to support the BI300 implant as determined by the surgeon
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04320407
Start Date
September 30 2020
End Date
December 28 2021
Last Update
November 25 2022
Active Locations (4)
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1
Arizona Ear Center
Phoenix, Arizona, United States, 85004
2
Center for Neurosciences
Tucson, Arizona, United States, 85718
3
University of Michigan
Ann Arbor, Michigan, United States, 48109-5312
4
Center for Hearing and Balance
Chesterfield, Missouri, United States, 63017