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Standardized Active Middle-Ear Implant Coupling to the Short Incus Process
Robert Mlynski1, Ernst Dalhoff, Andreas Heyd
1*Department of Otorhinolaryngology, Head and Neck Surgery "Otto Koerner" University Medical Center Rostock, Rostock; †Department of Otolaryngology, Section of Physiological Acoustics and Communication, University of Tübingen, Tübingen; and ‡Department of Oto-Rhino-Laryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, Comprehensive Hearing Center, University of Würzburg, Würzburg, Germany.
A new floating-mass transducer (FMT) coupler attached to the short incus process demonstrates effective mechanical and functional coupling for sensorineural hearing loss treatment. This alternative surgical approach shows promising results in temporal bone preparations and clinical practice.
Area of Science:
- Otolaryngology
- Biomedical Engineering
- Hearing Restoration
Background:
- Active middle-ear implants utilize floating-mass transducer (FMT) technology for mild-to-severe sensorineural hearing loss.
- Standard FMT vibroplasty involves attaching the device to the long incus process via mastoidectomy and posterior tympanotomy.
- An alternative, potentially less invasive, fixation site at the short incus process is explored.
Observation:
- The study developed and tested a novel coupling device (SP2 coupler) for attaching the FMT to the short incus process.
- Vibration responses were measured in human temporal bone preparations comparing the SP2 coupler to standard long incus process attachment.
- Functional outcomes were assessed in two patients with mild-to-severe hearing loss using the SP2 coupler.
Findings:
- The SP2 coupler exhibited comparable mean velocity-amplitude responses to the standard method in temporal bone models, with enhanced amplitudes at specific frequencies (0.7-1.5 kHz) and reduced variation (0.5-3 kHz).
- Clinical data showed good vibroplasty thresholds and significant improvements in speech understanding in quiet and noise for patients using the SP2 coupler.
- The SP2 coupler demonstrated effective mechanical and functional coupling in both experimental and clinical settings.
Implications:
- The short incus process attachment using the SP2 coupler offers a viable alternative for FMT vibroplasty.
- This approach may reduce surgical trauma compared to the standard long incus process fixation.
- The findings support the clinical utility of the SP2 coupler for improving hearing in sensorineural hearing loss patients.
