Osia CPT Code Study

  • days left to enroll
  • participants needed
  • sponsor
Updated on 13 May 2021


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

Condition Mixed conductive and sensorineural hearing loss, Conductive hearing loss, mixed hearing loss
Treatment Osia 2 system
Clinical Study IdentifierNCT04320407
Last Modified on13 May 2021


Yes No Not Sure

Inclusion Criteria

Cohort 1 Osia
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

Cohort 1 Osia
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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