Hearing Loss Clinical Trial
Official title:
Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
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.
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.
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