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We report an ex vivo and in vivo experimental study of a device designed to measure tympanic membrane movement under normal and pathological conditions, assessed using optical coherence tomography.
Materials and methods:
We designed two types of flexible, round film patch with integrated strain gauge, to be attached to the tympanic membrane in order to measure tympanic membrane movement. Tympanic membrane attachment was assessed using optical coherence tomography. The devices were tested experimentally using an ex vivo model with varying middle-ear pressure.
Optical coherence tomography reliably assessed attachment of the film patch to the tympanic membrane, before and after middle-ear pressure changes. Strain gauge voltage changes were directly proportional to middle-ear pressure recordings, for low pressure changes. Tympanic membrane perforations smaller than 2 mm could be sealed off with the film patch.
Attachment of the film patch with integrated strain gauge to the tympanic membrane was not ideal. Nevertheless, the strain gauge was able to precisely detect small pressure changes within the middle ear, in this experimental model.
To demonstrate the technique and clinical application of vibroplasty in which the floating mass transducer component of the Vibrant Soundbridge implant is coupled directly to the oval window niche, in patients with a mobile stapes footplate but a malformed or destroyed stapes suprastructure.
The underlying concept was to create a soft tissue casing for the floating mass transducer, while also firmly connecting the transducer to a small, solid cartilage ‘plunger’ attached to the stapes footplate. This was realised by removing almost all the cartilage from a larger piece of cartilage–perichondrium, leaving only a tiny cartilage island about half a millimetre in diameter, attached to a much wider ‘blanket’ of perichondrium.
By coupling the floating mass transducer directly to the oval window niche, patients' speech understanding was improved. Post-operative aided thresholds of 30–40 dB HL were achieved by all patients.
In patients with mixed hearing loss combined with a destroyed stapes suprastructure but a mobile stapes footplate, we describe the coupling of the floating mass transducer component of a Vibrant Soundbridge to the stapes footplate, as an alternative to coupling to the round window.
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