Today at the Ear, Nose, and Throat Advisory Committee of the FDA a meeting is under way to consider whether to recommend approval of Envoy Medical‘s (St. Paul, Minn) fully implantable hearing aid. The Esteem device uses a piezoelectric sensor to monitor the eardrum and convert the signal into digital for processing. The processed information is then converted back into physical vibrations and applied to the stapes capitulum. MedPage Today is reporting that in a recent clinical trial the device improved the hearing of a good number of subjects, but almost half experienced some sort of adverse effects such as taste disturbance and facial palsy.
The Esteem™ Totally Implantable Hearing Device (TIMED) is a totally implantable hearing system that is implanted under the skin behind the ear and in the middle ear space. The Esteem™’s purpose is to help improve hearing in adult patients who have mild to severe sensorineural hearing loss, and who have at least 60% or better discrimination of words (WRS). The goal is to provide comfortable, natural sounding, high fidelity sound to participants with sensorineural hearing loss by direct driving of inner ear fluid.
The Esteem™ device consists of: (1) a Sensor-PZT transducer that serves as a microphone, (2) an implantable Esteem™ Sound Processor containing a non-rechargeable battery, (3) connecting IS1-like leads that detach from the Sound Processor, and (4) a Driver-PZT transducer that vibrates the stapes. There is no external hardware, and the ear canal is not occluded. Control and programming of the Esteem™ are achieved through transcutaneous telemetry. Black arrows indicate the pathway that sensed sound energy travels through the Esteem™ system. The second (incus) and third (stapes) hearing bones are separated to prevent feedback vibrations.
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Product page: Esteem-Hearing Implant…