Cochlear, the Australian company best known for cochlear implants, says it has finished signing up all the volunteers for its two key trials of a hearing implant that sits entirely under the skin, with no outside parts. The company announced on 28 September 2026 that recruitment was complete for its worldwide program of pivotal trials, the large studies a device maker runs to support an application for approval1. In total, 92 adults have joined the two studies1.
A standard cochlear implant has two pieces: a part placed inside the head during surgery and a sound processor worn on the outside. The experimental system in these trials puts a microphone under the skin to pick up speech and other sound, “providing the option to hear without any visible external parts,” according to the trial registry2.
What happened
The two studies are called ELEVATE and ENTERPRISE. ELEVATE runs in the United States and is designed to include 56 adults at 11 clinical sites. ENTERPRISE runs in Australia and France and is designed to include 36 adults at five sites1. Both are testing the device in adults with moderately severe to profound hearing loss1.
A Cochlear-sponsored registry record for a pivotal study of 56 adults, listing the implant as TI1132, now shows the study as active but no longer recruiting. It started on 3 April 2026, and its main data collection is expected to finish in October 20272. A trial listing site that mirrors the record also shows it as not recruiting, last updated on 3 October 20263.
Cochlear also said people across its research programs on this technology have now spent more than 1 million hours in total living with the device1. Counting earlier small feasibility studies going back to 2005, 117 patients have been enrolled across the company’s two pivotal and three feasibility studies, and more than 100 have received a fully implantable Cochlear device1.
What the trials will measure
Cochlear plans a primary analysis of safety and effectiveness six months after the devices are switched on, with follow-up continuing to 12 months for longer-term data1. The registry lists two main measures: how well people recognize speech in quiet, comparing before the implant with six months after activation, and how often side effects and device problems occur up to 6 and 12 months after activation2. Participants also complete hearing tests and questionnaires on how the system affects daily life2.
The studies are open to adults who already have significant nerve-related hearing loss in both ears. For the ear to be implanted, entry rules require a hearing threshold of at least 70 decibels across four common pitches and a score of 40% or less on a word recognition test while wearing hearing aids3. Volunteers also need access to a compatible smartphone3.
Some people are left out by design. The rules exclude anyone with a previous cochlear implant, people with severe hearing loss in both ears before age 5, people whose implanted ear has had severe loss for more than 20 years, people with deafness in only one ear, and pregnant or breastfeeding women, among others3. That means early results will describe a fairly specific group of adults, not everyone who might one day want such an implant.
What it does not show yet
Finishing enrollment is a step in the process, not a result. Cochlear itself states that the system “is not approved for commercial distribution,” that safety and effectiveness “have not yet been established,” and that regulators must evaluate it before it can be approved1. No speech, safety or battery results from ELEVATE or ENTERPRISE have been released.
The 1 million hours figure is the company’s tally of total time people have worn its experimental devices across several programs1. It describes how much experience exists, not how well the devices performed or how often problems arose. The announcement does not give rates of side effects, device failures or removals from earlier studies.
Cochlear’s own list of lessons from three generations of the device hints at the hard parts. It named four needs: all-day hearing in everyday settings with a long-lasting implant battery; internal dual microphones meant to cancel body noise, along with simpler surgery and programming; a familiar surgical technique to limit extra operating and anesthesia time; and confidence built on long-term data1. Whether the new device meets those needs is what the trials are meant to find out.
The US lead investigator also urged patients not to hold off on current care. “Fully implantable technology holds great promise, but people who could benefit from a cochlear implant today should not wait for these future devices,” said Professor Craig Buchman of University of Utah Health1.
Who is behind it
Cochlear sponsors the trials2, and the announcement summarized here is the company’s own press release1. Cochlear’s employees and contractors working on the study are barred from enrolling as participants3. The company’s current commercial implant is the Nucleus Nexa System1.
Chief executive Dig Howitt said the company now has “more than 20 years of experience across three generations of investigational devices”1. Buchman is the coordinating investigator of ELEVATE, and Professor Christophe Vincent of Lille University Hospital is an investigator in ENTERPRISE1. Vincent said ENTERPRISE “will show how fully implantable hearing technology performs in everyday life”1. The sources do not describe any payments to investigators beyond the company’s role as sponsor.
How it fits the field
Cochlear is not alone. Envoy Medical, a Minnesota company, is testing its own fully implanted cochlear implant, called Acclaim, in a US pivotal trial4. Instead of a microphone, Envoy says its device uses a sensor designed to capture sound through the ear’s natural anatomy4. The FDA gave Acclaim Breakthrough Device Designation, a status meant to speed review of promising devices, in 20194.
Envoy says its trial is fully enrolled and that, as of 1 April 2026, its first three patients had completed their 12-month check, the point its main goals are tied to4. The company says it plans to apply for FDA approval after all participants finish their 12-month visits4. Envoy already sells a different fully implanted device, the Esteem middle ear implant, approved in the US and on the market since 2010 for moderate to severe hearing loss4. Like Cochlear’s, Envoy’s figures come from company statements, not published trial data.
Part of the case both companies make is about uptake. Envoy, citing a 2022 study, says only six percent of eligible people receive cochlear implants, and argues that devices with no outside hardware could appeal to people unwilling or unable to wear one4. That is a company’s argument; neither trial is set up to test whether fully hidden devices change how many people choose an implant.
What to watch next
- Six-month results. Cochlear’s main safety and effectiveness analysis is planned six months after switch-on1, with the US study’s main data collection expected to wrap up in October 20272.
- Side effects and device problems. The registry tracks these to 12 months2; how often devices need fixing or removal will matter as much as hearing scores.
- Regulatory filings. Cochlear says follow-up will continue as it moves toward regulatory submissions1, but it has not given a date.
- The race with Envoy. Envoy says it plans an FDA approval application once its 12-month data are complete4.
Biohack will follow this thread as results and regulatory steps arrive.
