Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)

NCT02022085 | Completed Results

• 1 other identifier: CBAS5477
• Study Type: interventional
• Target: 54
• Locations: 4 countries
• Sites: 6

Brief Summary

The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery:

• to evaluate the efficacy of the Baha Attract System in terms of hearing performance compared to the unaided situation and compared to a pre-operative test situation using the sound processor on a Baha Softband;
• to evaluate the mid- and long-term safety of the Baha Attract System.

Conditions

Deafness; Hearing Loss; Hearing Loss, Conductive

Outcome Measures

Primary Outcomes (4)

• Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract

  The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

  Baseline (unaided) before surgery, 6, 12 and 24 months after surgery

• Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract

  The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

  Baseline (unaided) before surgery, 24 months after surgery

• Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract

  The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz). The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

  Baseline (unaided) before surgery, 12 months after surgery

• Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract

  The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

  Baseline (unaided) before surgery, 6 months after surgery

Secondary Outcomes (19)

• Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract

  Baseline (unaided) before surgery, 6, 12 and 24 months after surgery

• Speech in Quiet, Baha Attract Versus Unaided

  Baseline before surgery, 6, 12 and 24 months after surgery

• Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract

  Baseline before surgery, 6, 12 and 24 months after surgery

• Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband

  Baseline (aided) before surgery, 6 months after surgery

• Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband

  Baseline (aided) before surgery, 12 months after surgery

Study Arms (1)

Baha Attract System

EXPERIMENTAL

This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; * One implant magnet * One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)

Device: Baha Attract System

Interventions

Baha Attract System DEVICE

The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Baha Attract System

Eligibility Criteria

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

You may qualify if:

• Adult subject, i.e. ≥ 18 years of age
• Conductive or mixed hearing loss in the ear to be implanted:
• Bone conduction thresholds with a pure tone average PTA4 of \< 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz).
• Single-sided sensorineural deafness (SSD):
• European sites: Bone conduction thresholds with a pure tone average PTA4 of \< 30dB hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear.
• US sites: Air conduction thresholds with a pure tone average PTA4 of 20 dB hearing level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS.
• No previous bone conduction implant on the side of the skull to be implanted. Signed informed consent.

You may not qualify if:

• Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness.
• Less than 3 mm soft tissue thickness at the planned implant site. Subjects that have received radiation therapy at the same side of the skull where the Baha Attract System will be positioned.
• Condition that could jeopardise osseointegration and/or wound healing as judged by the investigator (e.g. osteoporosis, psoriasis, use of corticosteroids).
• Uncontrolled diabetes as judged by the investigator. Condition that may have an impact on the outcome of the investigation as judged by the investigator.
• Unable to follow investigational procedures (e.g. to complete quality of life scales).
• Participation in another investigation with pharmaceuticals and/or medical device.

Sponsors & Collaborators

• Cochlear Bone Anchored Solutions: lead

Study Sites (6)

Dr. Doug Backhus

Seattle, Washington, 98122, United States

Location

Christina Runge

Milwaukee, Wisconsin, 53227, United States

Location

Dr. Myrthe Hol

Nijmegen, Netherlands

Location

World Hearing Center Institute of Physiology and Pathology of Hearing

Kajetany, Nadarzyn, 05-830, Poland

Location

Peter Monksfield

Birmingham, United Kingdom

Location

Kevin Green

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Deafness; Hearing Loss; Hearing Loss, Conductive

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: Professor Emmanuel Mylanus
• Organization: Radboud University Medical Centre, Nijmegen, The Netherlands

Emmanuel.Mylanus@radboudumc.nl

+31 24 361 1111

Study Officials

• Johan Blechert, M.Sc

  Cochlear Bone Anchored Solutions AB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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: December 16, 2013
• First Posted: December 27, 2013
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: November 1, 2017
• Last Updated: October 12, 2018
• Results First Posted: December 9, 2016

Record last verified: 2018-10

Locations

GB (2); NL (1); US (2); PL (1)