Osia CPT Code Study

Conductive Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320407
• Other study ID #: CAM5778
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: December 28, 2021

Study information

• Verified date: September 2022
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 28, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural
• Mixed Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Center for Hearing and Balance	Chesterfield	Missouri
United States	Arizona Ear Center	Phoenix	Arizona
United States	Center for Neurosciences	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Preoperative, 3 months post-surgery
Secondary	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.	6 months post-surgery