50 Participants Needed

Cochlear Implants for Hearing Loss

(ACE Trial)

Recruiting at 9 trial locations
LE
Overseen ByLavin Entwisle
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cochlear
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

Is cochlear implantation generally safe for humans?

Cochlear implants have been used in over 150,000 people worldwide, including young children, and while device failure is a risk, they are generally considered safe. A study on the SONATATI 100 cochlear implant also supports its safety in both adults and children.12345

How is cochlear implantation different from other treatments for hearing loss?

Cochlear implantation is unique because it directly stimulates the hearing nerve with electrical signals, bypassing damaged hair cells in the ear, unlike hearing aids that simply amplify sound. This makes it particularly beneficial for individuals with severe to profound hearing loss who do not benefit from traditional hearing aids.678910

What data supports the effectiveness of the treatment Cochlear Implantation for hearing loss?

Cochlear implants significantly improve hearing in patients with severe to profound hearing loss, often outperforming conventional hearing aids. They enhance word recognition and lipreading abilities, and improve quality of life, although additional auditory training may be needed to maximize benefits.1112131415

Are You a Good Fit for This Trial?

This trial is for adults with bilateral sensorineural hearing loss who don't currently qualify for cochlear implants under FDA guidelines. Participants will be assessed over seven visits after receiving the implant.

Inclusion Criteria

Meets audiometric criteria for the non-implanted contralateral ear: clinically established SNHL with a four frequency PTA at 500, 1000, 2000, & 4000 Hz of >30 dB HL
I have severe hearing loss and struggle to understand words even with a hearing aid.
Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator
See 1 more

Exclusion Criteria

Pregnant or breastfeeding women
Meets current indications on audiometric thresholds for traditional adult CI candidates
I do not have a cochlear nerve or my cochlea is undeveloped.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cochlear Implantation

Participants will be implanted with a commercially approved Cochlear™ Nucleus® implant

1 day
1 visit (in-person)

Post-implantation Assessment

Participants complete speech perception assessments and questionnaires over the course of seven visits

6 months
7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cochlear Implantation
Trial Overview The study is testing the Cochlear™ Nucleus® System to see if it's safe and works well in improving hearing for those who have significant hearing loss but aren't eligible for current treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cochlear™ Nucleus® SystemExperimental Treatment1 Intervention

Cochlear Implantation is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Cochlear Implant for:
🇪🇺
Approved in European Union as Cochlear Implant for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials
96
Recruited
6,300+
Headquarters
Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD

Althea Anagnostopoulos Harrington

Collaborator

Trials
2
Recruited
110+

MV Clinical Research, LLC

Collaborator

Trials
2
Recruited
110+

LWB Consulting

Collaborator

Trials
2
Recruited
110+

NAMSA

Collaborator

Trials
55
Recruited
21,500+

Published Research Related to This Trial

Cochlear implants significantly improve hearing in profoundly hearing-impaired patients, with performance in a study of 63 patients showing a wide range of outcomes, including up to 62% correct word recognition and 98% enhancement in lipreading.
Prelingually deaf children benefit from cochlear implants but take longer to show improvements compared to postlingually deaf individuals, highlighting the need for tailored rehabilitation approaches.
What can we learn about hearing aids from cochlear implants?Tyler, RS.[2019]
Cochlear implants (CIs) provide significantly better hearing improvement for patients with severe to profound hearing loss compared to conventional hearing aids, making them a more effective treatment option.
The MED-EL multichannel CI system has shown high reliability, with no technical failures reported over a 5-year observation period, highlighting the advancements in implant technology and design.
Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy.Baumann, U., Stöver, T., Weißgerber, T.[2022]
Cochlear implants, which send electrical impulses directly to the cochlear nerve, are a significant advancement for patients with severe hearing loss who cannot benefit from traditional hearing aids, and they are now being used in pediatric patients as well.
A multidisciplinary team approach is crucial for the successful implantation and follow-up care of cochlear implants, with 29 patients having received implants using a preferred multi-channel intracochlear system, demonstrating a positive impact on their quality of life.
[Cochlear implants in children].Garabedian, EN., Moatti, L., Roger, G., et al.[2006]

Citations

What can we learn about hearing aids from cochlear implants? [2019]
Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. [2022]
[Cochlear implants in children]. [2006]
Health-related quality of life in cochlear implanted patients in Romania. [2015]
Maximizing cochlear implant patients' performance with advanced speech training procedures. [2021]
HiRes ultra series cochlear implant field recall: failure rates and early outcomes. [2023]
Voluntary Field Recall of Advanced Bionics HiRes Cochlear Implants: A Single-Institution Experience. [2023]
A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees. [2022]
The MED-EL SONATATI 100 cochlear implant: an evaluation of its safety in adults and children. [2013]
Machine learning for pattern detection in cochlear implant FDA adverse event reports. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Cochlear implants in children. [2022]
[Cochlear implants]. [2015]
Cochlear implant assessment: imaging issues. [2019]
Cochlear implants and electrical brainstem stimulation in sensorineural hearing loss. [2019]
[AUDITORY BRAINSTEM IMPLANTS (ABI) IN CHILDREN: CASE SERIES IN SHAARE ZEDEK MEDICAL CENTER]. [2023]
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