Candidacy guide
Fully Implantable Cochlear Implants: Where TICI UNICO and Envoy Acclaim Stand
MED-EL's TICI UNICO has a CE Mark. Envoy's Acclaim is in an FDA trial. Neither is U.S. approved. What it means for candidates in Westchester. Book testing.
Read time: 7 min read
If you have severe hearing loss, you may have read that cochlear implants are about to disappear from view. Two companies are indeed building implants with no sound processor on the outside. In the United States, though, neither is approved or for sale. At Audiology Associates of Westchester, Dr. Caitlin Dold does candidacy testing and programming for cochlear implants. This page explains the two devices in plain terms and what to do while you wait.
The two devices
“Neither fully implantable cochlear implant can be offered in the United States today. A candidacy evaluation can start now.”
MED-EL announced TICI UNICO on September 29, 2026. It carries a European CE Mark. MD+DI reported on October 19, 2026 that the battery is expected to last 15 years or more and that recipients hear while it charges. Envoy Medical's Acclaim is a different design. Envoy says it uses a sensor that draws on the natural anatomy of the ear, not a microphone under the skin. Acclaim is investigational. The FDA granted it Breakthrough Device Designation in 2019, which speeds review but is not approval. Our earlier page on the [invisible cochlear implant TICI UNICO](/invisible-cochlear-implant-med-el-tici-unico) covers the MED-EL launch in more detail.
What the evidence shows so far
Envoy reports that its pivotal trial enrolled 56 people and that the last was implanted on March 11, 2026. For the first 10 patients, it reports average CNC word scores of 15.2 percent before surgery, 39.2 percent at six months and 53.2 percent at 12 months. CNC is a test of single-syllable words heard in quiet. For TICI UNICO, MED-EL says the data so far show performance comparable to established implants, and the release we read gave no numbers. All of this comes from companies. We have not seen independent results from either device over many years.
Where each device stands with the FDA
Envoy is filing its FDA application in four parts. It sent the first part on June 30, 2026 and the second on October 12, 2026. It targets the last part, which holds the clinical data, for the second quarter of 2027. Envoy gave no date for a decision. MED-EL has stated no U.S. plan in the material we read. A CE Mark reflects European conformity review, and the FDA decides separately. So the safe summary is simple: no fully implantable cochlear implant can be offered in the United States today, including by us.
Fully implantable implants at a glance
Here are the two devices side by side, using company releases and trade reports. Where a cell says the material we read is silent, we have not filled the gap.
What this means if you have severe hearing loss
Do not wait for a device that has no U.S. date. Three companies sell implant systems in the United States now: Advanced Bionics, Cochlear and MED-EL. All use an outside processor. For the right candidate they give large gains in understanding speech, most of all in quiet and on the phone. Hearing that goes unused for years tends to do worse after implantation, so delay has a cost. An evaluation does not commit you to surgery. It gives you a baseline that stays useful if new devices arrive. Our page on [when hearing aids are no longer enough](/when-hearing-aids-no-longer-enough-cochlear-implant) lists the warning signs, and our guide to the [60/60 rule](/what-is-the-60-60-rule-in-audiology) explains a common referral screen.
What Dr. Dold does, and what the surgeon does
Dr. Dold first checks that your hearing aids deliver what they should, using real-ear measurement. A poor fit can look like a candidacy problem. She then tests each ear, with and without devices, and explains how your results compare with candidacy criteria. If an implant makes sense, we refer you to an implant surgeon, and the surgery happens at a hospital. After healing, Dr. Dold activates the processor and programs it, and mapping continues through follow-up visits. Read about [cochlear implant support](/how-we-can-help/cochlear-implants), [processor upgrades such as the Integro](/integro-cochlear-implant-upgrade-westchester) and [Dr. Dold](/meet-the-team/caitlin-dold).
Questions to ask any implant team
Ask whether a device is approved or still in a trial. Ask what happens at the end of a battery's life and whether that needs another operation. Ask about MRI conditions. Ask how the device handles noisy rooms. Ask your insurer for a benefits check, because many insurers cover current implants when criteria are met, but we know of no decision about either device here. Medicare's rules matter too, and our page on [Medicare open enrollment and hearing benefits](/medicare-open-enrollment-hearing-benefits) is a starting point.
Next steps in Harrison and Somers
Book a [hearing evaluation](/hearing-testing) at our [Harrison office](/harrison-ny) or our [Somers office](/Somers-NY). If hearing aids have not helped as you hoped, a [hearing aid second opinion](/hearing-aid-second-opinion) can show whether the fit or the hearing loss is the problem. Other news this week: [Sony's exit from OTC hearing aids](/sony-exits-otc-hearing-aids), [SPI-1005 and sudden hearing loss](/spi-1005-menieres-sudden-hearing-loss) and [hearing aids and the longevity study](/hearing-aids-and-longevity-study).
Status and last update
Last updated October 19, 2026. This is the first version. We will revise it if the FDA acts on Acclaim, if Envoy submits its final module or if MED-EL announces a U.S. filing.
Medical information notice
Common questions
Does Audiology Associates of Westchester offer TICI UNICO or Acclaim?
No. Neither has FDA approval, so no U.S. practice can offer it yet. We do candidacy testing before cochlear implant surgery and programming after it, with Dr. Caitlin Dold.
What is the difference between TICI UNICO and Acclaim?
TICI UNICO uses a microphone under the skin and has a CE Mark in Europe. Acclaim uses a sensor that draws on the ear's anatomy, according to Envoy, and is in a U.S. clinical trial.
When might a fully implantable implant be approved in the U.S.?
No one has given a date. Envoy targets the last part of its FDA application for the second quarter of 2027, and the FDA decides after that. MED-EL has stated no U.S. plan.
Should I delay an implant evaluation to wait for one?
No. Waiting has a cost, and an evaluation does not commit you to surgery. It also gives you a baseline.
Who does the surgery?
An implant surgeon operates at a hospital. Our part is the testing beforehand and the activation and programming afterward.
What do we still not know?
Prices, insurance decisions, long-term results, noise performance compared with an outside processor and, for Acclaim, MRI details. Neither company has shared these in the material we read.
Neither device is approved in the U.S.
Get one email the week anything changes.
