Osia CPT Code Study

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

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

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss; Mixed Hearing Loss
• Intervention / Treatment: Device: Osia 2 System

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona Ear Center
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5312
      • University of Michigan
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Center for Hearing and Balance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cochlear
• Investigators: Principal Investigator: Mark Syms, MD, Arizona Hearing Center

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): October 5, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: conductive hearing loss; mixed hearing loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: CAM5778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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

Drug and device information, study documents

• 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