·Echoes of a Miracle
Frequently Asked Questions

TheAnswers

Plain answers to common questions about the trial, the device, and the patient.

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·Answers

Frequently Asked

Plain answers to common questions about the trial, the device, and the patient.

  1. What is the Envoy Medical Acclaim, and how is it different from a regular cochlear implant?
    The Envoy Medical Acclaim is a fully implanted cochlear implant. Traditional cochlear implants rely on an external sound processor worn behind the ear. The Acclaim sits entirely beneath the skin. There’s nothing visible, nothing to take off at night, and nothing to remove before showering, swimming, or sleeping. It uses your natural ear anatomy to pick up sound instead of an external microphone.
  2. Is the Acclaim completely internal?
    Yes. No microphone, no processor, no battery to wear, and nothing in your ear canal. I shower, sleep, swim, and live with it like any other part of my body. Most of the time, I forget it’s there.
  3. What is an early feasibility study?
    It’s the first FDA-authorized step in clinically evaluating a new medical device. It involves a very small number of patients, three, in the Acclaim case, and focuses on safety and basic device function. The device stays investigational the whole time, limited by federal law to investigational use until FDA approval is granted.
  4. Who is Patient CI3?
    That’s me. Michael Seufer, a designer and single father from Columbus, Ohio. CI3 is my trial designation, the third of three patients implanted in the Acclaim early feasibility study at Mayo Clinic. The published outcomes paper notes that I’m the only patient in the EFS using the device without a hearing aid for additional gain.
  5. Can I get the Acclaim now?
    Not yet. The device is still investigational and limited by federal law to investigational use until FDA approval is granted. The trial has moved into its pivotal phase, and enrollment for that phase is currently closed.
  6. Is the Acclaim covered by insurance?
    Not while it’s still investigational. Once it’s FDA-approved, the expectation is that it will be covered the same way traditional cochlear implants are.
  7. Where can I read the research?
    Dornhoffer JR, DeJong MD, Driscoll CLW, Saoji AA. Early Hearing Outcomes and Audiological Experiences With a Novel Fully Implanted Cochlear Implant. Otology & Neurotology 45(10):e727–e734, December 2024. PubMed: 39514428.
  8. Why does this site exist?
    To keep a public record of what happened during the Mayo Clinic Acclaim early feasibility study, told accurately, with sources cited. My case has implications that go beyond one trial, and I want it documented somewhere clinicians, researchers, journalists, and other patients can actually find it.
  9. What was my hearing like before the procedure?
    Profound sensorineural hearing loss in both ears. I could hear sound, but I couldn’t understand speech without lip-reading or captions. Phone calls, conversations, everyday sounds, most of it was either impossible to process or required a huge amount of effort.
  10. Why did I volunteer for the clinical trial?
    My son Mickey was the main reason. I wanted to hear him clearly and actually be present in his life. The second reason was the trial itself, a chance to contribute to research that could help a lot of other people with hearing loss.
  11. What happened during the activation appointment?
    The moment the implant was turned on, I was overwhelmed. All I heard was robotic, distorted noise. When Dr. Saoji clapped his hands, it sounded like a digitized racquetball hitting a wall. I was devastated. I turned the implant off in the Mayo parking garage and started the drive home.
  12. What did the sounds initially sound like?
    Metallic, digital, screeching. Nothing resembling speech or anything familiar. It was chaos. The Acclaim was a prototype being activated in a human for the first time, and no one in the room knew what to expect.
  13. How long did it take me to understand speech?
    I didn’t understand any speech during activation. I turned the device off, pretty discouraged, and started driving home. About thirty minutes into the drive the next morning, I started recognizing bits of my own voice. By the fourth hour of driving, my own voice was clear. By the fourth day, the screeching faded completely and everything was clear. Most cochlear implant recipients take weeks or months of rehab before speech becomes consistently understandable.
  14. What made my experience so unusual?
    My brain adapted in a few days. According to the study team, no one else in the trial adapted that quickly or that completely. The published outcomes paper documents me as the only patient in the EFS using the device without a hearing aid for additional gain.
  15. How has the procedure changed my daily life?
    It changed everything. I can talk on the phone, follow conversations without lip-reading, and actually engage with people instead of working around hearing loss. It’s like I was unplugged from the world and suddenly reconnected.
  16. How does sound feel now compared to before?
    Natural. Not mechanical, not robotic. My brain just understands it. There’s no conscious effort involved.
  17. What were the biggest challenges after surgery?
    Waiting for activation was the hardest part. Several weeks of healing without knowing whether the device would work. The adaptation itself, even though it went quickly, was also mentally exhausting in those first few days.
  18. Can I still use phones, headphones, and earbuds?
    Yes, and there’s nothing special I have to do. Because the Acclaim uses my natural ear canal, ordinary devices just work. No Bluetooth pairing to the implant, no dongles, no extra hardware. I hold my iPhone to my ear, or pop in AirPods, or wear over-ear headphones, all of it works the way it would for anyone else.
  19. Do people know I have a hearing device?
    Not unless I tell them. There are no visible parts. The incisions healed well, and the scars aren’t noticeable in ordinary settings.
  20. What has surprised me the most?
    How emotional it was to hear things again, especially my son’s voice. It feels like a second chance at experiencing life in new ways.
  21. How did my son react to my new hearing?
    He smiled a lot, started telling me longer stories, and just loved that he could talk to his dad knowing he was being heard.
  22. How do I describe what happened to other people?
    A second chance at life. I get to re-experience things I’d been missing for years and fill in the gaps. That’s the miracle of it.
  23. What advice do I have for others with hearing loss?
    Don’t give up hope. Technology is changing fast, and you never know what breakthrough is around the corner. Keep asking questions, stay informed, and stay open to possibilities.
  24. Am I still involved in the trial?
    Yes. I’ve been asked to participate in the second phase, the pivotal clinical trial, and that’s currently ongoing.
  25. Am I allowed to talk publicly about the trial?
    Yes. I have full permission from both Envoy Medical and Mayo Clinic to share my story and my experiences.
  26. Why did I start a public outreach campaign?
    To raise awareness of fully implanted cochlear technology, inspire others living with hearing loss, and open doors for future patients. I also use the platform to advocate for better access and better insurance coverage of hearing health.
  27. What’s my relationship with Envoy Medical and Mayo Clinic?
    I’m a participant in their clinical trial. I’m not employed by either, and I have no financial relationship with them beyond my role as a patient.
  28. Am I available for speaking engagements?
    Yes. I speak publicly about the trial, the device, and the broader experience of hearing loss and hearing technology. For media, conferences, panels, or private events, reach out through the contact form.
  29. How can someone support this advocacy work?
    Follow, share, reach out. Every bit of visibility helps reach the people who need to know this research is happening.
  30. Where can I follow the journey?
    On this site, through the News archive, and through the contact form for direct inquiries. More channels will be added as the project grows.