N/A Completed N=54 Treatment

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

Deafness · Hearing Loss · Hearing Loss, Conductive

Source: ClinicalTrials.gov NCT02022085 ↗

Enrolled (actual)

Serious AEs

24.1%

Results posted

Dec 2016

Primary outcomePrimary: Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract — -21.0; -20.9; -21.5 dB — p=<0.0001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract	-21.0; -20.9; -21.5	<0.0001 sig
PRIMARY Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract	-16.9; -26.6; -26.4; -18.7; -16.9; -12.3	<0.0001 sig
PRIMARY Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract	-16.9; -26.6; -26.4; -18.7; -16.9; -12.3	<0.0001 sig
PRIMARY Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract	-16.9; -26.6; -26.4; -18.7; -16.9; -12.3	<0.0001 sig
SECONDARY Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract	-4.30; 4.79; -4.47	<0.0001 sig
SECONDARY Speech in Quiet, Baha Attract Versus Unaided	52.1; 43.4; 13.3; 50.7; 45.5; 13.9	<0.0001 sig
SECONDARY Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract	-0.62; 0.196; -0.136	0.38
SECONDARY Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband	-3.67; -1.74; -1.20; -0.761; 2.61; 3.15	0.0051 sig
SECONDARY Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband	-3.67; -1.74; -1.20; -0.761; 2.61; 3.15	0.0051 sig
SECONDARY Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband	-3.67; -1.74; -1.20; -0.761; 2.61; 3.15	0.0051 sig
SECONDARY Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband	-0.508; -1.05; -0.739	0.46
SECONDARY Speech in Quiet: Baha Attract Versus Sound Processor on Softband	2.74; -2.11; -0.33; 0.373; -2.69; -0.961	0.43
SECONDARY Health Utility Index (HUI)	0.063; -0.003; 0.111; 0.045; -0.016; -0.021	0.088
SECONDARY Abbreviated Profile of Hearing Aid Benefit (APHAB)	20.4; 26.3; 22.0; 1.32; 22.9; 18.7	<0.0001 sig
SECONDARY Speech, Spatial and Qualities of Hearing Scale (SSQ)	2.49; 1.87; 1.68; 2.07; 1.36; 1.30	<0.0001 sig
SECONDARY Time to Perform Surgery	38.7	—
SECONDARY Tissue Reduction Performed During Surgery	12; 42	—
SECONDARY Implant Stability	77.3	—
SECONDARY Magnetic Force	1.01; 1.07; 1.15; 1.16; 1.15; 1.09	—
SECONDARY Sound Processor Magnet Choice	19; 19; 9; 6; 1; 0	—
SECONDARY Pain & Discomfort	21; 15; 15; 2; 24; 16	—
SECONDARY Numbness When Tested With a Pin	12; 9; 33; 15; 7; 32	—
SECONDARY Numbness When Tested With a Cotton Swab	13; 9; 32; 18; 6; 30	—

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).

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.

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Data sourced from ClinicalTrials.gov (NCT02022085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.