Back to resultsOsia CPT Code Study
Primary Purpose
Conductive Hearing Loss, Mixed Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osia 2 System
Sponsored by
About this trial
This is an interventional treatment trial for Conductive Hearing Loss focused on measuring conductive hearing loss, mixed hearing loss
Eligibility Criteria
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
Sites / Locations
- Arizona Ear Center
- Center for Neurosciences
- University of Michigan
- Center for Hearing and Balance
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Osia 2 System
Arm Description
Osia 2 Active Osseointegrated Implant System for Bone Conduction
Outcomes
Primary Outcome Measures
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 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
Number of Device or Procedure Related Adverse Events
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04320407
Brief Title
Osia CPT Code Study
Official Title
A Post-market Interventional Cohort Study Evaluating the Clinical Efficacy of the Osia 2 System in the US Market.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
October 5, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conductive Hearing Loss, Mixed Hearing Loss
Keywords
conductive hearing loss, mixed hearing loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osia 2 System
Arm Type
Experimental
Arm Description
Osia 2 Active Osseointegrated Implant System for Bone Conduction
Intervention Type
Device
Intervention Name(s)
Osia 2 System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery
Description
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.
Time Frame
Preoperative, 3 months post-surgery
Secondary Outcome Measure Information:
Title
Number of Device or Procedure Related Adverse Events
Description
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.
Time Frame
6 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Syms, MD
Organizational Affiliation
Arizona Hearing Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Ear Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5312
Country
United States
Facility Name
Center for Hearing and Balance
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request
Learn more about this trial
Osia CPT Code Study
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