Osia CPT Code Study

Cochlear

Status

Completed

Conditions

Mixed Hearing Loss

Conductive Hearing Loss

Treatments

Device: Osia 2 System

Study type

Interventional

Funder types

Industry

Identifiers

CAM5778

Details and patient eligibility

About

To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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