Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

NCT04754477 | Completed Results

• 1 other identifier: CBAS5793
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

Brief Summary

The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.

Conditions

Hearing Loss

Keywords

Hearing Loss, Conductive; Hearing Loss, Mixed; Deafness, sensorineural single-sided

Outcome Measures

Primary Outcomes (6)

• Number and Type of Reported Adverse Events

  The adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system

  6 months post-surgery to 24 months post-surgery

• Number and Type of Reported Device Deficiencies

  The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship

  6 months post-surgery to 24 months post-surgery

• Concomitant Medication Used

  Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)

  6 months post-surgery to 24 months post-surgery

• Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey

  Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected

  12 months post-surgery

• Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey

  Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected

  24 months post-surgery

• Change in Audiometric Thresholds With the Active Osseointegrated Steady-State Implant System at 12 Months Post-surgery and 24 Months Post-surgery Compared to Preoperative Thresholds Via an Audiogram

  Bone- and air conduction thresholds, masked and unmasked

  Baseline before surgery, 12 months and 24 months post-surgery

Secondary Outcomes (22)

• Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 Months and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds

  3 or 6 months post-surgery, 12 and 24 months post-surgery

• Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Audiometric Thresholds

  3 or 6 months post-surgery, 12 and 24 months post-surgery

• Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Adaptive Speech Recognition in Noise

  3 or 6 months post-surgery, 12 and 24 months post-surgery

• Change in Hearing Performance With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study Assessed Via Bone Conduction (BC) Direct

  3 or 6 months post-surgery, 12 and 24 months post-surgery

• Difference in Self-reported Hearing Outcome With the Active Osseointegrated Steady-State Implant System at 12 and 24 Months Post-surgery Compared to Last Performed Measurement (3 or 6 Months) in the CBAS5751 Study

  3 or 6 months post-surgery, 12 and 24 months post-surgery

Study Arms (1)

Active Osseointegrated Steady-State Implant System (OSI)

EXPERIMENTAL

Device: Active Osseointegrated Steady-State Implant System (OSI)

Interventions

Active Osseointegrated Steady-State Implant System (OSI) DEVICE

System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process

Active Osseointegrated Steady-State Implant System (OSI)

Eligibility Criteria

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

You may qualify if:

• Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
• Willing and able to provide written informed consent

You may not qualify if:

• Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
• Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator

Sponsors & Collaborators

• Cochlear: lead
• Statistiska Konsultgruppen: collaborator

Study Sites (3)

SCIC / NextSense

Gladesville, New South Wales, 2111, Australia

Location

HEARnet Clinical studies

Carlton, Victoria, 3053, Australia

Location

Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• Cowan R, Lewis AT, Hallberg C, Tong MCF, Birman CS, Ng IH, Briggs R. Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):683-691. doi: 10.1007/s00405-023-08133-3. Epub 2023 Aug 8.

  PMID: 37552281 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

• Karin Ganlöv, MD

  Cochlear

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: February 10, 2021
• First Posted: February 15, 2021
• Study Start: May 6, 2021
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: June 10, 2024
• Results First Posted: June 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); HK (1)