Osia CPT Code Study
Completed · Not applicable
Conditions studied: Conductive Hearing Loss, Mixed Hearing Loss
In brief
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
Key facts
- Study ID
- NCT04320407
- Run by
- Cochlear
- People needed
- 20
- Starts
- 2020-09-30
- Expected to finish
- 2021-12-28
- Last updated by the study team
- 2022-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Arizona Ear Center — Phoenix, Arizona, United States
- Center for Neurosciences — Tucson, Arizona, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Center for Hearing and Balance — Chesterfield, Missouri, United States
Full record on ClinicalTrials.gov
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