Cochlear Implant for Hearing Loss

(ELEVATE Trial)

Not yet recruiting at 10 trial locations

Overseen By PRS Specialist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Prior cochlear implantation, Single-sided deafness, Intra-axial lesions, Middle ear infection, Tympanic membrane perforation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of cochlear implant that remains fully hidden under the skin. It aims to assist individuals with sensorineural hearing loss, which occurs when the inner ear or auditory nerve is damaged. The study will evaluate the implant's effectiveness and its impact on daily life through hearing tests and surveys. Individuals who struggle with hearing despite using hearing aids and understand less than 40% of spoken words may be suitable candidates for this trial. As an unphased trial, participants can contribute to groundbreaking research that could significantly enhance hearing solutions.

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 team or your doctor.

What prior data suggests that this cochlear implant system is safe for adults with sensorineural hearing loss?

Research shows that the Totally Implantable Cochlear Implant (TICI) system is safe and effective in people. Studies have found that the TICI system helps individuals hear as well as traditional implants. The primary goal of ensuring the device's safety was achieved. Improvements in hearing were significant, and no serious safety issues emerged. Participants in earlier studies experienced positive results without major side effects. This suggests that the TICI system is a safe option for those with sensorineural hearing loss, providing an effective solution without visible external parts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Totally Implantable Cochlear Implant (TICI) System is unique because it offers a fully implantable solution for hearing loss, unlike traditional cochlear implants that require external components. Researchers are excited about TICI because it allows for more natural hearing experiences and eliminates the need for visible external devices, which can be a significant concern for many users. This innovative approach not only aims to improve sound quality but also enhances convenience and aesthetics for individuals with hearing loss, making it a promising advancement in the field.

What evidence suggests that this cochlear implant is effective for hearing loss?

Studies have shown that the Totally Implantable Cochlear Implant (TICI) system, which participants in this trial will receive, can greatly improve hearing in people with sensorineural hearing loss. One study found that participants experienced an average improvement of 1.84 on a scale measuring speech and sound recognition, indicating significantly better hearing with the device. The TICI system provides hearing levels similar to traditional cochlear implants but remains completely under the skin, making it less noticeable. This design could enhance everyday experiences for users. ^{1 2 3 4 5}

Who Is on the Research Team?

Craig Buchman

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with sensorineural hearing loss, which is caused by damage to the inner ear or auditory nerve. Participants should be able to complete hearing tests and questionnaires about how their hearing affects daily life.

Inclusion Criteria

I have significant hearing loss in one ear, confirmed by a specific hearing test.

My hearing, even with aids, scores ≤40% in word recognition tests.

Clinically established SNHL defined by a four-frequency (500, 1000, 2000 & 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the contralateral ear

Exclusion Criteria

Unable or unwilling to comply with all requirements of the clinical investigation, as determined by the investigator

Pregnant or breastfeeding women

I don't have health issues that prevent me from having surgery or anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants are implanted with the TI1132 implant

1 week

1 visit (in-person)

Activation and Initial Testing

Initial activation of the implant and baseline hearing tests

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits at 6 and 12 months post-activation

What Are the Treatments Tested in This Trial?

Interventions

• Totally Implantable Cochlear Implant (TICI) System

Trial Overview

The study is testing a new totally implantable cochlear implant (TICI) system that includes an under-the-skin microphone for detecting sounds without visible external parts. Its effectiveness and impact on quality of life are being evaluated.

How Is the Trial Designed?

Group I: Totally Implantable Cochlear Implant System Experimental Treatment 1 Intervention

Participants will be implanted with the TI1132 implant

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

Citations

1.

blog.medel.pro

blog.medel.pro/products-updates/totally-implantable-cochlear-implant-tici-feasibility-study-results/

The Future of Cochlear Implants: Experts Discuss Totally ...

Experts share their experiences leading the feasibility study on MED-EL's Totally Implantable Cochlear Implant (TICI).

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41243136/

Evaluation of a Totally Implantable Cochlear Implant in ...

Speech, Spatial, and Qualities of Hearing scale showed a significant mean improvement of 1.84 (95% CI, 1.00 to 2.65) compared with baseline.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07287124

NCT07287124 | A Pivotal Study to Evaluate the Clinical ...

This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system.

4.

journals.lww.com

journals.lww.com/ear-hearing/fulltext/9900/evaluation_of_a_totally_implantable_cochlear.514.aspx

Evaluation of a Totally Implantable Cochlear Implant in...

The cochlear implant (CI) has been demonstrated to be an effective intervention for restoring functional hearing in adults and children with ...

5.

nature.com

nature.com/articles/s43856-024-00719-0

Rehabilitation of human hearing with a totally implantable ...

The TICI provides high levels of hearing performance, comparable to those of a conventional CI. The development of the TICI expands the range of ...