Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 9
- Primary Endpoint
- Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
Study Overview
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.
Detailed Description
This investigation was designed to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that were candidates for Baha surgery.
The investigation was performed in an open design since it was not possible to perform the investigation in a blinded fashion. The main evaluations of the investigation, i.e. free-field hearing tests, are standard audiological procedures that are routinely used in daily clinical practice at hospitals worldwide for evaluation of hearing performance in hearing impaired patients. The primary efficacy evaluation, audiometric thresholds, renders comparable results across different sites and countries as it is not a language-specific test. Language-specific audiological tests were performed as secondary efficacy evaluations; to enable comparison of data across sites, validated word lists were used at all sites and equivalent speaker configurations (speech from front, noise from behind) and test procedures (same noise and adaptive speech levels, etc) were used.
For the primary evaluation in the investigation, the Baha Attract System was compared to the pre-operative unaided situation, as the intended use of the system is to improve hearing performance in patients with conductive or mixed hearing loss or single-sided sensorineural deafness. Audiological test results with the Baha Attract System were also compared against results obtained with the same Sound Processor on a Baha Softband. Use of the Sound Processor on a Softband is a standard procedure that is routinely used as a pre-operative test prior to bone conduction hearing implant surgery. The Softband test allows the patient to pre-operatively experience hearing through the Sound Processor to get an indication of the post-operative hearing outcome and to choose a suitable Sound Processor.
The generic and hearing-specific quality of life questionnaires used in the investigation (HUI3, APHAB, SSQ) are validated scales that have been frequently used and reported in the literature.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Baha Attract System (however, bilateral hearing loss is not an exclusion criterion).
- •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.
Arms & Interventions
Baha Attract System
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)
Intervention: Baha Attract System (Device)
Outcomes
Primary Outcomes
Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
Time Frame: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
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.
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
Time Frame: Baseline (unaided) before surgery, 6 months after surgery
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.
Secondary Outcomes
- Speech in Quiet, Baha Attract Versus Unaided(Baseline before surgery, 6, 12 and 24 months after surgery)
- 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 Sound Processor on Softband(Baseline (aided) before surgery, 6, 12 and 24 months after surgery)
- Abbreviated Profile of Hearing Aid Benefit (APHAB)(Baseline before surgery, 6 and 24 months after surgery)
- Speech, Spatial and Qualities of Hearing Scale (SSQ)(Baseline before surgery, 6 and 24 months after surgery)
- Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband(Baseline (aided) before surgery, 6, 12 and 24 months after surgery)
- Health Utility Index (HUI)(Baseline (unaided) before surgery, 6 and 24 months after surgery)
- Tissue Reduction Performed During Surgery(Visit 2 (surgery))
- Numbness When Tested With a Pin(Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24)
- Numbness When Tested With a Cotton Swab(Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24)
- Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract(Baseline before surgery, 6, 12 and 24 months after surgery)
- Time to Perform Surgery(Visit 2 (Surgery))
- Implant Stability(Visit 2 (surgery))
- Sound Processor Magnet Choice(4, 6, 12 weeks, 6, 12 and 24 months)
- Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband(Baseline (aided) before surgery, 24 months after surgery)
- Pain & Discomfort(Week 6, Week 12, Month 6, Month 12, Month 24)
- Magnetic Force(4, 6, 12 weeks, 6, 12 and 24 months)