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Active Middle Ear Implants
Built from Haynes-Glasscock-Shambaugh Surgery of the Ear, Seventh Edition
What’s inside
11 sections · 105 slides
Overview
- Scope of this presentation
The unmet need in hearing rehabilitation
- Burden of hearing loss and hearing aid uptake
- Medical contraindications to conventional aids
- Public health consequences of untreated hearing loss
Limitations of conventional amplification
- Five limitations of conventional hearing aids
- Insufficient gain in moderately severe and severe loss
- Distortion and the occlusive seal
- Behind-the-ear aid with occlusive earmould
- Open-fit aids and transduction inefficiency
- How active middle ear implants address these limits
Basic design features
- Signal pathway of an active middle ear implant
- Electromagnetic transducers
- Piezoelectric transducers
- Coupling sites for the transducer
- Semi-implantable and fully implantable configurations
- Partially implanted devices
- Fully implantable devices
- Cochlear tonotopy and the implant target
- Frequency map of the cochlea in the intact ear
Challenges and opportunities
- Professional endorsement and current status
- Cost and reimbursement barriers
- Device longevity compared with cochlear implants
- Cost-effectiveness evidence
- Industry instability and regulatory burden
- Quality of the evidence base
The three FDA-approved devices
- Reading the device comparison
- Distinctions between the FDA-approved active middle ear implants
- FDA-approved indication for each device
MED-EL Vibrant Soundbridge
- Development history of the Vibrant Soundbridge
- Components of the Vibrant Soundbridge
- Working principle of the vibrating ossicular prosthesis
- Indications for the Vibrant Soundbridge
- Degrees of hearing loss plotted on the audiogram
- Range of pathology treated with the Soundbridge
- Mixed hearing loss on pure tone audiometry
- Surgical technique for Soundbridge implantation
- Crimping force on the incus long process
- Postoperative threshold shift with the Soundbridge
- Functional gain compared with hearing aids
- Speech discrimination with the Soundbridge
- Systematic review in conductive and mixed loss
- Patient-reported outcomes with the Soundbridge
- Quality of life in external otitis and bilateral implantation
- Explantation and revision rates
- Revision by coupling site
- Other adverse events and comparative safety
- MRI compatibility of the Vibrant Soundbridge
Ototronix MAXUM
- From SOUNDTEC to MAXUM
- Components of the MAXUM system
- Ear canal coil and incudostapedial joint magnet in position
- Audiometric criteria for the MAXUM system
- Speech perception gap as a selection tool
- Overlap with cochlear implant candidacy
- Preoperative ear canal assessment
- Surgical technique for MAXUM implantation
- Magnet positioning and functional gain
- Avoiding contact of the magnet
- Threshold change after implantation
- Significant threshold shifts after surgery
- Functional gain over best-fit hearing aids
- Speech discrimination results
- MAXUM in potential cochlear implant candidates
- Patient-reported outcomes and complications
- Complications of MAXUM and SOUNDTEC implantation
- MRI compatibility of the MAXUM implant
Envoy Esteem
- Position of the Esteem among implants
- Signal path through the Esteem
- Implanted components of the Esteem
- Ossicular disarticulation and irreversibility
- Indications and preoperative imaging for the Esteem
- Space requirements on preoperative CT
- Surgical approach for the Esteem
- Transducer placement and feedback control
- Threshold and audiometric outcomes with the Esteem
- Speech testing results with the Esteem
- Patient-reported outcomes with the Esteem
- Device malfunction and explantation
- Infection, exposure and surgeon experience
- Facial nerve injury after Esteem surgery
- Proposed mechanisms of delayed facial paresis
- Revision surgery for the Esteem
- Other adverse events and MRI status
Summary
- Key points on active middle ear implants
- Outstanding barriers and future direction
References
- References
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- Haynes-Glasscock-Shambaugh Surgery of the Ear, Seventh Edition
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