A New Implantable Middle Ear Hearing Device for Mixed Hearing Loss: A Feasibility Study in Human Temporal Bones

Hypothesis: To assess the feasibility of a new, active middle ear device in temporal bones (TB). Background: This device is designed for patients with mixed hearing loss subsequent to chronic middle ear infection, surgery, or trauma. This Bell-Vibroplasty is built from a VIBRANT MED-EL Vibrant Soundbridge and a Kurz Bell titanium partial ossicular replacement prosthesis. Methods: In three fresh TBs, healthy and reconstructed middle ears were analyzed by means of laser Doppler interferometry. The sound transmission properties of a partial ossicular replacement prosthesis and a passive and an active Bell-Vibroplasty were compared with healthy middle ear function. Results: The measurements provided reliable results with small standard deviations and good signal-to-noise ratios. The performance levels of the partial ossicular replacement prosthesis and of the passive Bell-Vibroplasty were comparable with that of healthy middle ear function. The activated Bell-Vibroplasty provided linear function and a flat frequency response within the measured frequency range (500 Hz-8 kHz), with peak deviations of less than 10 dB. The maximum output of the Bell-Vibroplasty was equivalent to 125-dB sound pressure level. Conclusion: Bell-Vibroplasty is feasible in TBs. Bell-Vibroplasty performance in TBs is sufficient to allow for a clinical trial as a next step.

[1]  K. Schwager.  Titanium as a biomaterial for ossicular replacement: results after implantation in the middle ear of the rabbit , 1998, European Archives of Oto-Rhino-Laryngology.

[2]  A. Huber,et al.  Analysis of the best site on the stapes footplate for ossicular chain reconstruction. , 1999, Acta Oto-Laryngologica.

[3]  R. Goode,et al.  Effect of Changes in Mass on Middle Ear Function , 1993, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[4]  S. Schmerber,et al.  Hearing results with the titanium ossicular replacement prostheses , 2006, European Archives of Oto-Rhino-Laryngology and Head & Neck.

[5]  Mario A Ruggero,et al.  The roles of the external, middle, and inner ears in determining the bandwidth of hearing , 2002, Proceedings of the National Academy of Sciences of the United States of America.

[6]  N Yanagihara,et al.  Long-term results using a piezoelectric semi-implantable middle ear hearing device: the Rion Device E-type. , 2001, Otolaryngologic clinics of North America.

[7]  Thomas Lenarz,et al.  Clinical Experience with the Vibrant Soundbridge Implant Device , 2001, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[8]  A. Huber,et al.  Stapes Prosthesis Attachment: The Effect of Crimping on Sound Transfer in Otosclerosis Surgery , 2003, The Laryngoscope.

[9]  Ugo Fisch,et al.  Intraoperative Assessment of Stapes Movement , 2001, The Annals of otology, rhinology, and laryngology.

[10]  Ugo Fisch,et al.  Evaluation of Eardrum Laser Doppler Interferometry as a Diagnostic Tool , 2001, The Laryngoscope.