Question
Who is a candidate for the Esteem® hearing implant from Envoy Medical? If a patient is a candidate, what is the process?
Answer
The Esteem is appropriate for individuals 18 years or older with stable, moderate to severe sensorineural hearing loss, unaided word recognition of ≥ 40% on monosyllabic words, at least 30 days of experience with appropriately fit hearing aids, and enough space in the middle ear to allow for placement of the device.
If you have patients who are interested in and may be good candidates for the Esteem, you can either refer those patients to an Esteem Hearing Implant Certified Audiologist– a provider locator can be found on our website – or you can look into becoming an Esteem Hearing Implant Certified Audiologist yourself.
The candidacy process would start with an audiological evaluation. If an appropriate candidate audiometrically, the individual will meet with the implanting surgeon to determine surgical candidacy. If the implanting surgeon determines the individual is in fact an Esteem candidate, the surgeon will provide a detailed informed consent discussion prior to scheduling the surgery to insure the individual has appropriate expectations and is aware of the risks of surgery, such as taste disturbance.1
The surgical procedure typically takes about four hours and is performed under general anesthesia. The Esteem is activated by the audiologist after the ear has healed from surgery, usually about two months post-operatively. Initial gain settings at activation are generally lower than they will be after some acclimatization has occurred, and progressive programs may be created, where the individual can gradually increase the amount of gain by using a different program or a different volume step. The patient will return to the audiologist for an adjustment of the device a couple of months after activation. After that, they typically return for follow-up annually or as needed.
If you have a patient who is interested in the Esteem, you can always direct that patient to our website, www.esteemhearing.com, or have them directly contact our customer service department to request more information at info@esteemhearing.com or 877-900-3277. Our customer service representatives do an excellent job of introducing the Esteem to an interested patient by being able to answer a wide variety of basic questions about the Esteem.
NOTE: Esteem is approved for a specific type of hearing loss and can only be prescribed and surgically implanted by a trained physician. Risks include those typical for surgery. Side effects related to taste and facial movement are possible. It is possible that additional surgery may be required to resolve complications. Ask your doctor and audiologist if Esteem is right for you. Individual results may vary.
FDA IDE G070162, Esteem Totally Implantable Hearing System
1www.envoymedical.com (Important Safety Information)
