Osia CPT Code Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-12-28

Brief Summary

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

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Detailed Description

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Conditions

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Conductive Hearing Loss Mixed Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Osia 2 System

Osia 2 Active Osseointegrated Implant System for Bone Conduction

Group Type EXPERIMENTAL

Osia 2 System

Intervention Type DEVICE

The external Sound Processor, Osia 2 Active Osseointegrated Implant System for Bone Conduction, captures and digitizes the sound which is transferred to the internal implant where it is converted to an electrical signal.

Interventions

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Osia 2 System

The external Sound Processor, Osia 2 Active Osseointegrated Implant System for Bone Conduction, captures and digitizes the sound which is transferred to the internal implant where it is converted to an electrical signal.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No