March 2021 BusinessWire

An independent study published online in The Journal of Laryngology & Otology found that the fully implanted AMEI showed statistically significant improvements in post-operative hearing results. The study also reinforced the safety and efficacy of the Esteem® for patients with moderate-to-severe sensorineural hearing loss who have failed to benefit from traditional amplification like hearing aids. The study, “Totally implantable active middle-ear implants (AMEI): a large, single-surgeon cohort,” represented a large, retrospective, single-surgeon experience which demonstrated that the AMEI provided an overall significant improvement in pure tone average (PTA) and word recognition score at a hearing level of 50 dB.

Envoy EsteemEnvoy Medical's fully implanted Esteem® osseointegrated active middle ear implant (AMEI) 

“These study results provide further evidence to support the use of fully implanted active middle ear implants such as the Esteem for patients with moderate-to-severe sensorineural hearing loss who are unable to use or do not benefit from hearing aids,” said William McFeely, M.D., study author and otolaryngology specialist at North Alabama ENT Associates. “Large studies of patient outcomes with AMEI are still lacking largely due to the lack of insurance coverage, so patients who may benefit from these devices may not be offered an AMEI as a treatment option. However, many patients with hearing loss haven’t found hearing aids to be an optimal choice and are still searching for alternatives; AMEIs such as the Esteem represent an excellent alternative.”

This retrospective review was performed on 116 implants placed between November 2011 and August 2016 and included many patients who reported subjective suboptimal performance with traditional amplification and a lack of desire to continue using hearing aids. In addition to the statistically significant improvements in PTA and word recognition score, other key findings from this study included:

  • Active middle ear implants are a safe and effective option for patients with sensorineural hearing loss who have struggled with traditional hearing aids and are good surgical candidates
  • Although technically demanding, implantation is readily learned by an experienced otological surgeon
  • Complication rates are low
  • Further high quality, prospective data are needed to establish superiority of active middle ear implants compared with traditional hearing aids

Specialty hearing implants like the Esteem hearing implant are not covered by Medicare or Medicaid because they are incorrectly classified as a hearing aid.

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