Cochlear’s ELEVATE Clinical Trial: a new alternative to hearing aids
A clinical study evaluating an investigational fully implantable hearing technology.
For millions of people worldwide living with moderately severe-to-profound hearing loss, daily life often depends on hearing aids worn behind the ear that amplify sound but may not restore clarity. Conversations are strained, social gatherings exhausting and professional opportunities impacted by communication barriers.
Day after day, users manage batteries, feedback, background noise and the inability to hear when swimming, showering or sleeping. For many, understanding speech in complex listening environments often remains frustratingly limited.
Despite continual technological improvements, even high-powered hearing aids may provide only incremental benefit for those with advanced hearing loss, leaving many individuals seeking a more definitive, discreet, and performance-driven solution.
The ELEVATE Clinical Trial is evaluating a fully implantable hearing technology for adults living with moderately severe-to-profound hearing loss. Using only a discreet charging solution when you choose, the investigational system is designed to deliver continuous sound in daily life without requiring anything to be worn externally.
If your hearing aids are no longer enough, it's important to speak with a hearing professional to understand your options. Participation in the study is voluntary and should not replace a discussion about currently available treatment options.Hearing and your health
Why treating hearing loss early is important
Clearer hearing can help reduce the mental effort of listening, supporting memory and focus so you can stay sharp, independent and connected.1-3
Hearing loss and brain health
The effects of hearing loss go far beyond sound. When your brain does not receive clear signals, it can become harder to concentrate, follow conversations or remember details.4,6
If you are one of the many adults living with hearing loss, your hearing may reach a point where even the most powerful hearing aids are no longer enough. That is when it’s time to talk to a hearing health professional about the next step to help you hear more clearly.
Is hearing loss affecting your clarity of mind?
While wearing hearing aid(s):
- Do you feel mentally tired after conversations?
- Do you struggle to follow conversations in noisy environments?
- Do you ask people to repeat themselves?
- Do you turn the TV louder than others prefer?
If these sound familiar, your hearing aids may no longer be giving you the clarity you need. It may be time to talk to your hearing health professional about options to support clearer hearing and greater quality of life.1-3,5
How the investigational device works
The ELEVATE Clinical Trial is evaluating the performance of a fully implantable hearing technology.
The ELEVATE clinical trial device is a fully implantable, investigational hearing technology. Using only a discreet charging solution when you choose, the investigational system is designed to deliver continuous sound in daily life without requiring anything to be worn externally.
The trial device includes:
- Fully implanted hearing device and microphone
- An external implant charger that can also function as a sound processor worn behind the ear when the user prefers
- Next-generation technology designed to replicate the natural pathway of hearing — delivering balanced, high-fidelity sound perception in everyday listening situations
Inspired by individuals who have persevered for years with severe hearing loss, the ELEVATE clinical trial reflects Cochlear’s commitment to restoring connection, confidence and quality of life.
About the clinical trial
Clearer hearing can help reduce the mental effort of listening, supporting memory and focus so you can stay sharp, independent and connected.1-3 If you are interested in learning more at the ELEVATE Clinical Trial, please talk with your hearing provider or fill out the contact form.
More information about the trial can also be found on ClinicalTrials.gov.
Clinical Trial information
The ELEVATE Clinical Trial examines the performance of a fully implantable hearing technology. This investigational system* includes an implantable microphone under the skin designed to detect speech and sound from the environment. Using only a discreet charging solution when you choose, the investigational system is designed to deliver continuous sound in daily life without requiring anything to be worn externally.
We are looking for participants in a clinical research trial evaluating a fully implantable hearing technology in those living with moderately severe-to-profound hearing loss. Eligibility will be determined by the clinical study team.
Even if you do not qualify for this trial, you may still be a candidate for other implantable hearing solutions. Continuing discussions with your hearing healthcare professional can help identify the hearing device options best suited to your needs today.
Once the study team has confirmed that you may be eligible and you consent to participating, you will undergo surgery to receive the fully implantable hearing technology at no cost to you.
As part of the trial, you will need to attend scheduled hearing tests and questionnaires before and after surgery at different time points for up to 16 months. These visits are to evaluate how the technology is performing. The study team will explain all procedures, potential risks and benefits to you before you decide whether to participate.
The ELEVATE clinical trial will allow us to learn if using the technology with or without an external device worn behind the ear successfully provides hearing and lifestyle benefits to patients. This is a research device that needs to be examined for performance and safety before it can be approved for use by the Food and Drug Administration and made available to eligible patients.
By taking part in the study, you will:
- Have access to the care you need and play an active role in hearing research.
- Help us understand how we can help others like you.
- Receive compensation for your time and for modest ground transportation.
For more information, please contact one of the participating centers directly, or complete the form below to receive more information.
Sign up for announcements
Don’t miss the latest information about the ELEVATE Clinical Trial – sign-up for important announcements.
Where is the trial taking place?
The following 11 centers are participating in the ELEVATE Clinical Trial:
University Hospitals Cleveland Medical Centre, Principal Investigator: Alejandro Rivas
Rocky Mountain Ear Center, Principal Investigator: David Kelsall
University of Iowa, Principal Investigator: Bruce Gantz
Midwest Ear Institute, Principal Investigator: Robert Cullen
University of Miami School of Medicine, Principal Investigator: Sandra Prentiss
New York University, Principal Investigator: J. Thomas Roland
Michigan Ear Institute, Principal Investigator: Robert Hong
Hearts for Hearing Foundation, Principal Investigator: Rene Gifford
Mayo Foundation Rochester, Principal Investigator: Matthew Carlson
University of Utah Hospitals and Clinics, Principal Investigator: Richard Gurgel
Washington University School of Medicine, Principal Investigator: Jacques Herzog
Disclaimer
Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always follow the directions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.
©Cochlear Limited 2026. All rights reserved. Cochlear, Hear now. And always, Nucleus, Kanso, Baha, Osia, the elliptical logo, and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of the Cochlear group of companies (unless otherwise noted).
CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.
* This is an investigational device and not yet approved for commercial use.
References
- Shukla A, Harper M, Pedersen E, Goman A, Suen JJ, Price C, et al. Hearing Loss, Loneliness, and Social Isolation: A Systematic Review. Otolaryngology--head and neck surgery: official journal of American Academy of Otolaryngology-Head and Neck Surgery. 2020;162(5):622–33.
- Lawrence BJ, Jayakody DMP, Bennett RJ, Eikelboom RH, Gasson N, Friedland PL. Hearing Loss and Depression in Older Adults: A Systematic Review and Meta-analysis. The Gerontologist [Internet]. 2020:e137–54.
- Shoham N, Lewis G, Favarato G, Cooper C. Prevalence of anxiety disorders and symptoms in people with hearing impairment: a systematic review. Social psychiatry and psychiatric epidemiology. 2019;54(6):649–60.
- Huang AR, Jiang K, Lin FR, Deal JA, Reed NS. Hearing Loss and Dementia Prevalence in Older Adults in the US. JAMA. 2023;329(2):171–3. doi: 10.1001/jama.2022.20954.
- Yeo BSY, Song HJJMD, Toh EMS, Ng LS, Ho CSH, Ho R, et al. Association of Hearing Aids and Cochlear Implants With Cognitive Decline and Dementia: A Systematic Review and Meta-analysis. JAMA neurology [Internet]. 2023;80(2):134–41.
- Bess FH, Hornsby BWY. Commentary: Listening Can Be Exhausting—Fatigue in Children and Adults with Hearing Loss. Ear and hearing 2014;35(6):592–9.