Osia CPT Code Study

Sponsor

Cochlear (Industry)

Overall Status

Completed

CT.gov ID

NCT04320407

Collaborator

(none)

Enrollment

Locations

Arm

14.9

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Conductive Hearing Loss Mixed Hearing Loss	Device: Osia 2 System	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Post-market Interventional Cohort Study Evaluating the Clinical Efficacy of the Osia 2 System in the US Market.

Actual Study Start Date :

Sep 30, 2020

Actual Primary Completion Date :

Oct 5, 2021

Actual Study Completion Date :

Dec 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Osia 2 System Osia 2 Active Osseointegrated Implant System for Bone Conduction	Device: 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. Reference device for Cohort 1 Osia: Baha 5 Power sound processor on the Baha Sound Arc.

Arm

Intervention/Treatment

Experimental: Osia 2 System

Osia 2 Active Osseointegrated Implant System for Bone Conduction

Device: 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. Reference device for Cohort 1 Osia: Baha 5 Power sound processor on the Baha Sound Arc.

Outcome Measures

Primary Outcome Measures

Adaptive speech in noise test for Osia 2 system. [3 months]
To demonstrate significant difference between the aided and unaided conditions in Osia 2 arm at 3 months using an adaptive speech in noise test when compared to the preoperative (Visit 1) unaided condition.

Secondary Outcome Measures

Incidence of device or procedure related adverse events [6 months post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Ear Center	Phoenix	Arizona	United States	85004
2	Center for Neurosciences	Tucson	Arizona	United States	85718
3	University of Michigan	Ann Arbor	Michigan	United States	48109-5312
4	Center for Hearing and Balance	Chesterfield	Missouri	United States	63017