Clinical Trial: Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months F

Brief Summary:

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

Detailed Summary:
Sponsor: Cochlear Bone Anchored Solutions

Current Primary Outcome:

• Hearing Performance, PTA4 at 12 Weeks [ Time Frame: Baseline before surgery and 12 weeks after surgery ]
  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.
• Hearing Performance, PTA4 at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.

Original Primary Outcome:

• Hearing performance [ Time Frame: Baseline ]
  To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery. The following audiological tests will be performed:free field thresholds, speech recognition in noise and speech recognition in quiet
• Hearing Performance [ Time Frame: Week 4 ]
  To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery
• Hearing performance [ Time Frame: Week 6 ]
  To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery
• Hearing performance [ Time Frame: Week 12 ]
  To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery
• Hearing performance [ Time Frame: Week 30 ]
  To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery

Current Secondary Outcome:

• Hearing Performance, Individual Frequencies [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.
• Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.
• Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.
• Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.
• Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.
• Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.
• Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.
• Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
  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.

Original Secondary Outcome: Hearing Aid Outcome [ Time Frame: Baseline and week 12, 30 ]

Dates:
Date Received: March 19, 2013
Date Started: March 2013
Date Completion:
Last Updated: December 12, 2016
Last Verified: December 2016