The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery: * To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband * Which sound processor to select, i.e. BP100 vs BP110 * Improve the fitting process for the sound processor * Selection of sound processor magnet at time of fitting and over time
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The HEARing CRC & HearWorks, University of Melbourne
Melbourne, Victoria, Australia
Clinica Las Condes
Santiago, Chile
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Bnai Zion MedicalCenter
Haifa, Israel
Hearing Performance, PTA4 at 12 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.
Time frame: Baseline before surgery and 12 weeks after surgery
Hearing Performance, PTA4 at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Individual Frequencies
The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.
Time frame: Baseline before surgery and 36 weeks after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.
Time frame: Baseline before surgery and 36 weeks after surgery
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