Trial Outcomes & Findings for Osia CPT Code Study (NCT NCT04320407)

NCT ID: NCT04320407

Last Updated: 2022-11-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Preoperative, 3 months post-surgery

Results posted on

2022-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Osia 2 System Osia 2 Active Osseointegrated Implant System for Bone Conduction 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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Osia CPT Code Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Osia 2 System n=20 Participants Osia 2 Active Osseointegrated Implant System for Bone Conduction 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.
Age, Continuous	47.9 years STANDARD_DEVIATION 16.2 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: Preoperative, 3 months post-surgery

Outcome measures

Outcome measures
Measure	Osia 2 System n=20 Participants Osia 2 Active Osseointegrated Implant System for Bone Conduction 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.
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery	6.1 Score on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Osia 2 System n=20 Participants Osia 2 Active Osseointegrated Implant System for Bone Conduction 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.
Number of Device or Procedure Related Adverse Events	15 Number of events

Adverse Events

Osia 2 System

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Osia 2 System n=20 participants at risk Osia 2 Active Osseointegrated Implant System for Bone Conduction 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.
General disorders Post-operative pain	25.0% 5/20 • Number of events 5 • From the day of surgery (day 0) to 6 months post-surgery Adverse events with a frequency threshold \> 5% are reported.
General disorders Post-operative swelling	10.0% 2/20 • Number of events 2 • From the day of surgery (day 0) to 6 months post-surgery Adverse events with a frequency threshold \> 5% are reported.

Additional Information

PRS Specialist, Clinical Affairs

Cochlear

Phone: +61 2 9428 6555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI can't publish or discuss the results without the permission of the sponsor.
Publication restrictions are in place

Restriction type: OTHER