Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

NCT04041700 | Completed Results

• 1 other identifier: CBAS5751
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 3

Brief Summary

The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.

Conditions

Hearing Loss

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds

  Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)

  Baseline before surgery, 3 months after surgery

• Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise

  Speech-to-noise ratio, 50% speech understanding

  Baseline before surgery, 3 months after surgery

Secondary Outcomes (30)

• Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds

  Baseline before surgery, 4 weeks and 6 months after surgery

• Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise

  Baseline before surgery, 4 weeks and 6 months after surgery

• Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds

  Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

• Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet

  Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

• Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire

  Baseline before surgery, 3 months and 6 months after surgery

Study Arms (1)

Osia 2 system

EXPERIMENTAL

Device: Osia 2 system

Interventions

Osia 2 system 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 processor.

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:

• Subject with conductive hearing loss or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB sensorineural hearing loss.
• OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.
• Adult subjects (18 years or older).
• Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband).
• Candidate is a fluent speaker in the language used to assess speech perception performance.
• Willing and able to provide written informed consent

You may not qualify if:

• Uncontrolled diabetes as judged by the investigator.
• Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
• Insufficient bone quality and quantity to support successful implant placement.
• Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged by the investigator.
• Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
• 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.
• Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator.
• Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period.
• 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 employees of Contract Research Organisations 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 involving an investigational drug or device.

Sponsors & Collaborators

• Cochlear: lead
• Statistiska Konsultgruppen: collaborator

Study Sites (3)

Sydney Cochlear Implant Centre

Gladesville, Australia

Location

The Royal Victorian Eye and Ear Hospital

Melbourne, 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 (2)

• 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

• Briggs R, Birman CS, Baulderstone N, Lewis AT, Ng IHY, Ostblom A, Rousset A, Tari S, Tong MCF, Cowan R. Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2022 Aug 1;43(7):827-834. doi: 10.1097/MAO.0000000000003590.

  PMID: 35878640 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: Johan Blechert
• Organization: Cochlear

jblechert@cochlear.com

+46766498632

Study Officials

• Karin Ganlöv

  Cochlear

  STUDY DIRECTOR

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: July 30, 2019
• First Posted: August 1, 2019
• Study Start: August 16, 2019
• Primary Completion: June 19, 2020
• Study Completion: September 24, 2020
• Last Updated: August 18, 2021
• Results First Posted: August 18, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); HK (1)