Osia CPT Code Study

NCT04320407 | Completed Results FDA Device

• 1 other identifier: CAM5778
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Conductive Hearing Loss; Mixed Hearing Loss

Keywords

conductive hearing loss; mixed hearing loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Device or Procedure Related Adverse Events

  6 months post-surgery

Study Arms (1)

Osia 2 System

EXPERIMENTAL

Osia 2 Active Osseointegrated Implant System for Bone Conduction

Device: Osia 2 System

Interventions

Osia 2 System DEVICE

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.

Osia 2 System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cochlear: lead

Study Sites (4)

Arizona Ear Center

Phoenix, Arizona, 85004, United States

Location

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5312, United States

Location

Center for Hearing and Balance

Chesterfield, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: PRS Specialist, Clinical Affairs
• Organization: Cochlear

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Study Officials

• Mark Syms, MD

  Arizona Hearing Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: September 30, 2020
• Primary Completion: October 5, 2021
• Study Completion: December 28, 2021
• Last Updated: November 25, 2022
• Results First Posted: November 25, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)