Osia CPT Code Study

Not Applicable

Completed

• Conditions: Conductive Hearing Loss; Mixed Hearing Loss
• Interventions: Device: Osia 2 System

• Registration Number: NCT04320407
• Lead Sponsor: Cochlear

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-09-30
• Primary Completion: 2021-10-05
• Study Completion: 2021-12-28
• Status Verified: 2022-09
• Results First Submitted: 2022-09-29
• Results First Submitted QC: 2022-11-02
• Last Update Submitted: 2022-11-02
• Results First Posted: 2022-11-25
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Osia 2 System	Osia 2 System	Osia 2 Active Osseointegrated Implant System for Bone Conduction

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery	Preoperative, 3 months post-surgery	Assessed with the Quick SIN test preoperative and at 3 months post-surgery. The Quick SIN test has a score range from +25.5 dB (decibel) SNR (signal-to-noise ratio) to -5 dB SNR. The participants are tested on 4 tests lists; each consists of 6 sentences (with 5 key words per sentence) that are presented at signal-to-noise ratios (SNR) which are decreased manually in 5-dB steps from 25 to 0. The key words in sentences are scored and counted as correct from an easy to difficult or unfavorable SNR. The best possible score on this test would be that of -5 dB SNR where all of the key words are repeated back correctly as a function of the SNR. The mean unaided preoperative score is substracted from the aided score at 3 months. A lower score indicates a better performance.

Secondary Outcome Measures

Name	Time	Method
Number of Device or Procedure Related Adverse Events	6 months post-surgery	A device or procedure related adverse event (AE) is an AE for which a causal relationship between the use of the medical device and the AE cannot be ruled out. All related AEs are reported.

Trial Locations

Locations (4)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Center for Neurosciences; 🇺🇸 Tucson, Arizona, United States

Center for Hearing and Balance; 🇺🇸 Chesterfield, Missouri, United States

Arizona Ear Center; 🇺🇸 Phoenix, Arizona, United States