Invisible hearing loss aid Esteem Hearing Implant to hit US market soon: Envoy Medical

Esteem Hearing Implant, a fully implantable hearing restoration system developed by Envoy Medical, may hit the US market soon.

Esteem hearing aid device has been unanimously recommended by an Advisory Panel of independent ENT experts in US FDA.

The Advisory Panel’s vote is a recommendation only, and US FDA will still have to formally approve the Esteem before it can be marketed to the public, Envoy Medical said in a press announcement.

In most cases, the FDA does follow the Advisory Panel’s recommendation.

“Esteem allows recipients the opportunity to hear naturally and restore their lives back to normal,” Patrick Spearman, Envoy Medical’s chief executive officer, was quoted as saying.

Esteem is great news for all sensorineural hearing loss sufferers, he added.

In the clinical trial using Esteem, patients averaged an 11 decibel improvement in Speech Reception Threshold (SRT) scores beyond their hearing aids. At a quiet conversation level, average patient speech understanding improved by more than 45% over their hearing aids.

Esteem is surgically implanted, invisible to others.

The fully invisible Esteem Hearing Implant uses the body’s natural anatomy to provide optimal hearing. It is not affected by acoustic feedback.

Esteem Hearing Implant allows patients to live normal active lifestyles as there will be no occlusion effect (nothing in the ear) nor any maintenance or batteries for five to nine years.

How Esteem Hearing Implant works?

Hearing aids provide limited benefit because all hearing aid technology works outside the body providing amplification. Making sounds louder does not necessarily make them understandable if the auditory system is damaged (sensorineural hearing loss).

Esteem-Hearing Implant, in contrast, is not a simple sound amplifier. It enhances your own anatomy’s ability to process sound. The device enhances the energy delivered to the cochlea within the middle ear to correct the signals delivered to the auditory nerve.

Esteem Hearing Implants (similar to pacemaker technology) is implanted under the skin behind the ear. Two leads extend into the middle ear from the device. Sound waves travel into the ear canal and set the ear drum (tympanic membrane) into motion causing the bones of the middle ear to vibrate. The device senses these movements and delivers a customized dose of energy to the cochlea which transmits the signals to the brain. The brain interprets the signals as hearing, which in turn provides the patient with a New World of Sound.

Inner ear is the fluid-filled cochlea containing thousands of tiny sound receptors called hair cells. The hair cells sway with sound waves in the fluid filled space that sends a signal to the brain that is interpreted as sound, whereas the middle ear, which comprises the eardrum and three tiny bones vibrate from sound waves.

The natural ear collects sound from the environment and these sound waves create normal vibration of the eardrum.

Esteem Hearing Implants senses and process these natural vibrations by applying a customized dose of energy to the cochlea. The cochlea converts the energy and vibration into signals and the brain interprets the signals into sound.

Esteem Hearing Implant is surgically placed behind the ear. Typically, patients can go home early the next day after this painless surgery.

Esteem may cost approximately $30,000 (including the device, surgery and audiometric testing), in the US market.

Over 21.5 million adults in the United States suffer from sensorineural hearing loss. Conventional microphone-based hearing aids are the most common treatment today for sensorineural hearing loss.

However, only 20 to 30% of the hearing impaired use hearing aids and many who try hearing aids stop after a short period.

The most commonly sited limitations of hearing aids include poor understanding in noise, poor sound quality, whistling (acoustic feedback), battery life, poor fit and discomfort.

Minnesota-based Envoy Medical Corporation is a privately held company. It develops and market implantable devices for the treatment of sensory disorders.