Osia CPT Code Study (NCT04320407) | Clinical Trial Compass
CompletedNot Applicable
Osia CPT Code Study
United States20 participantsStarted 2020-09-30
Plain-language summary
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery