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Baha Attract System: 6-month results of a multicentre, open, prospective clinical investigation

Presenting Author: Myrthe Hol

Published online by Cambridge University Press:  03 June 2016

Peter Monksfield ,
Piotr Skarzynski ,
Kevin Green ,
Christina Runge ,
Stina Wigren ,
Johan Ivarsson Blechert ,
Mark Flynn ,
Arjan Bosman  and
Emmanuel Mylanus
Peter Monksfield
Affiliation:
Department of Otorhinolaryngology, Queen Elizabeth Hospital, Birmingham, United Kingdom
Piotr Skarzynski
Affiliation:
Cochlear Bone Anchored Solutions, Mölnlycke, Sweden
Kevin Green
Affiliation:
Department of Otorhinolaryngology, Queen Elizabeth Hospital, Birmingham, United Kingdom
Christina Runge
Affiliation:
Department of Otorhinolaryngology, Medical College of Wisconsin, Milwaukee Wisconsin, United States of America
Stina Wigren
Affiliation:
Department of Otorhinolaryngology, World Hearing Center, Institute of Physiology and Pathology of Hearing, Nadarzyn, Poland
Johan Ivarsson Blechert
Affiliation:
Department of Otorhinolaryngology, World Hearing Center, Institute of Physiology and Pathology of Hearing, Nadarzyn, Poland
Mark Flynn
Affiliation:
Department of Otorhinolaryngology, World Hearing Center, Institute of Physiology and Pathology of Hearing, Nadarzyn, Poland
Arjan Bosman
Affiliation:
Department of Otorhinolaryngology, Radboud university medical centre, Nijmegen, The Netherlands
Emmanuel Mylanus
Affiliation:
Department of Otorhinolaryngology, Radboud university medical centre, Nijmegen, The Netherlands
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Abstract

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Learning Objectives:

Objectives: Present the 6 months results of a multicentre, prospective investigation on the Cochlear™ Baha® Attract™ System.

Design: Fifty-four adult patients with hearing impairment, were included and underwent surgery in the current prospective cohort study. Follow-up visits were scheduled at 10 days, 4, 6 and 12 weeks, and 6 months. Main outcome measures are hearing performance (free-field audiometry, speech in quiet, adaptive speech in noise) with the Baha Attract System compared to the unaided situation and compared to a pre-operative test situation using the sound processor on a softband, safety of the Baha Attract System, hearing related quality of life, surgical information, sound processor magnet strength and magnetic retention force over time, and information on postoperative pain, discomfort, numbness and soft tissue status.

Results: The 6 months results of the multicentre will be presented for the main outcome measures.

Conclusions: The objective is to present data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery.