Clinical trial NCT02022085: Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
Official title: Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness
Hearing Loss
Hearing Loss, Conductive
Lead sponsor: Cochlear Bone Anchored Solutions
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

OR

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.

Primary outcomes:
measure: Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
timeFrame: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
measure: Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
timeFrame: Baseline (unaided) before surgery, 24 months after surgery
measure: Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
timeFrame: Baseline (unaided) before surgery, 12 months after surgery
measure: Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
timeFrame: Baseline (unaided) before surgery, 6 months after surgery
Secondary outcomes:
measure: Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract
timeFrame: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
measure: Speech in Quiet, Baha Attract Versus Unaided
timeFrame: Baseline before surgery, 6, 12 and 24 months after surgery
measure: Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract
timeFrame: Baseline before surgery, 6, 12 and 24 months after surgery
measure: Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
timeFrame: Baseline (aided) before surgery, 6 months after surgery
measure: Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
timeFrame: Baseline (aided) before surgery, 12 months after surgery
measure: Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
timeFrame: Baseline (aided) before surgery, 24 months after surgery
measure: Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband
timeFrame: Baseline (aided) before surgery, 6, 12 and 24 months after surgery
measure: Speech in Quiet: Baha Attract Versus Sound Processor on Softband
timeFrame: Baseline (aided) before surgery, 6, 12 and 24 months after surgery
measure: Health Utility Index (HUI)
timeFrame: Baseline (unaided) before surgery, 6 and 24 months after surgery
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Baseline before surgery, 6 and 24 months after surgery
measure: Speech, Spatial and Qualities of Hearing Scale (SSQ)
timeFrame: Baseline before surgery, 6 and 24 months after surgery
measure: Time to Perform Surgery
timeFrame: Visit 2 (Surgery)
measure: Tissue Reduction Performed During Surgery
timeFrame: Visit 2 (surgery)
measure: Implant Stability
timeFrame: Visit 2 (surgery)
measure: Magnetic Force
timeFrame: 4, 6, 12 weeks, 6, 12 and 24 months
measure: Sound Processor Magnet Choice
timeFrame: 4, 6, 12 weeks, 6, 12 and 24 months
measure: Pain & Discomfort
timeFrame: Week 6, Week 12, Month 6, Month 12, Month 24
measure: Numbness When Tested With a Pin
timeFrame: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24
measure: Numbness When Tested With a Cotton Swab
timeFrame: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Dr. Doug Backhus
state: Washington
city: Milwaukee
country: United States
facility: Christina Runge
state: Wisconsin
city: Nijmegen
country: Netherlands
facility: Dr. Myrthe Hol
city: Kajetany
country: Poland
facility: World Hearing Center Institute of Physiology and Pathology of Hearing
state: Nadarzyn
city: Birmingham
country: United Kingdom
facility: Peter Monksfield
city: Manchester
country: United Kingdom
facility: Kevin Green
Study officials:
affiliation: Cochlear Bone Anchored Solutions AB
name: Johan Blechert, M.Sc
role: STUDY_DIRECTOR
References: