Cochlear Implant for Hearing Loss

Recruiting at 5 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Med-El Corporation

Disqualifiers: Cochlear malformation, Ear infection, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a cochlear implant for individuals with hearing loss in one ear. It aims to assist those with single-sided deafness or uneven hearing between ears. The trial includes participants aged five and older with severe hearing loss in one ear and minimal to no issues in the other. Participants should have tried other hearing aids or devices before considering this implant. As an unphased trial, it offers a unique opportunity for participants to contribute to advancing treatment options for single-sided deafness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the MED-EL Cochlear Implant System is safe for cochlear implantation?

Research shows that the MED-EL Cochlear Implant System is generally safe and reliable over time. It has a high success rate, with 99.86% of implants functioning well after six years.

Some individuals have experienced temporary hearing loss (15.9% or 7 out of 44 people) and balance issues like dizziness or vertigo (9.1% or 4 out of 44 people) after receiving the implant. A smaller number reported tinnitus, affecting 4.5% or 2 out of 44 people.

Although these side effects can occur, the implant meets high safety and quality standards. Considering these factors is important when deciding whether to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MED-EL Cochlear Implant System for hearing loss because it offers a unique approach to restoring hearing. Unlike traditional hearing aids that simply amplify sound, cochlear implants work by directly stimulating the auditory nerve, which can be particularly beneficial for individuals with severe to profound hearing loss. The MED-EL system is known for its innovative electrode design that provides a more natural sound quality by covering a wider range of frequencies. This advanced technology has the potential to significantly improve the clarity and richness of sounds for users, making it a promising option for those who haven't benefited from conventional hearing aids.

What evidence suggests that the MED-EL Cochlear Implant System is effective for hearing loss?

Research shows that the MED-EL Cochlear Implant System, which participants in this trial will receive, helps people with hearing loss hear better. Studies have found that cochlear implant users often understand speech more clearly, even in noisy environments. For example, users report improved sentence comprehension and word recognition with the implant. Adults with hearing loss in one ear often notice improvements in pinpointing sound origins, reduced ear ringing, and enhanced quality of life. The device also demonstrates high reliability, with a 99.86% success rate over six years. This evidence supports the conclusion that cochlear implants can improve hearing and the overall listening experience. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults and children aged 5 or older with single-sided profound hearing loss, who have tried other hearing aids without success. They must have very poor word recognition in the affected ear and normal to moderate hearing in the other ear. People can't join if they've been profoundly deaf for over 10 years, have developmental issues, surgical risks, cochlear nerve problems, or severe inner ear abnormalities.

Inclusion Criteria

My hearing in the non-implanted ear is normal or has mild to moderate loss.

I have hearing loss in one ear without major issues in the outer or middle ear.

Fluent in English

Exclusion Criteria

I have hearing loss not caused by ear damage.

You have a severe problem with the structure of your inner ear.

I have an ear infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants undergo cochlear implantation

1 week

1 visit (in-person)

Post-implantation Follow-up

Participants are monitored for safety and effectiveness of the cochlear implant

36 months

Regular visits over 3 years

Long-term Monitoring

Long-term safety and performance of the cochlear implant are evaluated

36 months

What Are the Treatments Tested in This Trial?

Interventions

• MED-EL Cochlear Implant System

Trial Overview The study tests the long-term safety and effectiveness of MED-EL Cochlear Implant System in individuals with single-sided deafness or asymmetric hearing loss. It aims to see how well this implant works for those who haven't benefited from traditional or bone conduction hearing aids.

How Is the Trial Designed?

Group I: Study Procedure Experimental Treatment 1 Intervention

MED-EL Cochlear Implant System is already approved in European Union, United States for the following indications:

Approved in European Union as MED-EL Cochlear Implant System for:

• Single-sided deafness (SSD)
• Asymmetric hearing loss (AHL)
• Bilateral moderate-to-profound sensorineural hearing loss

Approved in United States as MED-EL Cochlear Implant System for:

• Single-sided deafness (SSD)
• Asymmetric hearing loss (AHL)
• Bilateral moderate-to-profound sensorineural hearing loss

Who Is Running the Clinical Trial?

Med-El Corporation

Lead Sponsor

Trials

27

Recruited

2,100+

Published Research Related to This Trial

In a study involving 16 adults with post-linguistic hearing impairment, access to bilateral acoustic hearing alongside cochlear implant stimulation significantly improved speech recognition in noisy environments, localization abilities, and subjective ratings of real-world benefits.

The findings suggest that combining acoustic hearing in both ears with electrical stimulation from a cochlear implant enhances overall hearing performance, indicating a strong advantage for patients with this configuration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of bilateral acoustic hearing in combination with electrical stimulation provided by the cochlear implant. Plant, K., Babic, L.[2017]

In three cases of cochlear implantation using the Med-El Combi 40+ device, significant improvements in hearing were observed shortly after surgery.

Postoperative assessments indicated notable advancements in both speech discrimination and speech production, highlighting the efficacy of the cochlear implant in enhancing auditory capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implantation with implant Combi 40+ produced by MED-El]. Ovchinnikov, IuM., Borodin, AA.[2006]

Cochlear implantation using the Oticon Medical Neuro system significantly improves speech identification in both quiet and noisy environments, with mean HINT scores increasing from 13% pre-operatively to 72% at 12 months post-activation.

The procedure demonstrated a high safety profile, with a 0% major complication rate during surgery and only a 4% rate of major complications in the year following activation, indicating that it is a safe option for adults with bilateral sensorineural hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study. Schramm, D., Chen, J., Morris, DP., et al.[2020]

A novel minimally invasive, image-guided technique for cochlear implantation was successfully validated in seven cadaver specimens, showing no visible injury to the facial nerve during the procedure.

Lateral wall electrodes from Cochlear demonstrated the least intracochlear trauma, indicating they may be the most suitable option for this surgical approach compared to other electrode types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of minimally invasive, image-guided cochlear implantation using Advanced Bionics, Cochlear, and Medel electrodes in a cadaver model. McRackan, TR., Balachandran, R., Blachon, GS., et al.[2021]

The MED-EL DUET system, which combines a hearing aid and cochlear implant, was generally well accepted by patients with sufficient low-frequency hearing preservation after cochlear implantation, as shown in a study of 15 subjects.

However, acceptance of the DUET system decreased significantly in patients who experienced greater loss of residual hearing, particularly those with losses exceeding 55 dB at 125 Hz or 70 dB at 250 Hz, indicating that postoperative hearing outcomes are crucial for the device's acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and fitting of the DUET device - a combined speech processor for electric acoustic stimulation. Helbig, S., Baumann, U.[2019]

The MED-EL Combi40+ cochlear implant system is safe and effective for treating severe to profound sensorineural hearing loss, with surgical complication rates and speech perception outcomes comparable to other cochlear implants, based on a review of 112 patients.

Postlingually deafened adults showed significant improvements in speech perception after one year of using the implant, achieving mean scores of 54% for CNC words and 87% for HINTQ, while prelingually deafened adults also benefited but had lower performance levels and more variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MED-EL Combi40+ cochlear implantation in adults. Bassim, MK., Buss, E., Clark, MS., et al.[2019]

Signal processing algorithms in cochlear implants (CIs) are designed to replicate the natural hearing function of the ear, significantly improving speech perception, especially in noisy environments.

Recent advancements, such as deep electrode insertion and enhanced sound processing strategies, have led to better music enjoyment and overall hearing experiences for CI users, exemplified by innovations like the RONDO audio processor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signal processing & audio processors. Dhanasingh, A., Hochmair, I.[2021]

The Otologics Fully-Implantable MET Ossicular Stimulator was safely implanted in 20 adult patients with moderate to severe sensorineural hearing loss, showing a functional gain of 10-20 dB across various frequencies.

While traditional hearing aids provided slightly better word recognition scores, patients reported greater overall satisfaction with the implant, suggesting it could be a viable alternative to conventional hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator. Jenkins, HA., Atkins, JS., Horlbeck, D., et al.[2007]

MED-EL's FLEX electrode array is available in five different lengths to accommodate the significant size variations in normal cochlear anatomy, ensuring optimal fitting for cochlear implant (CI) users.

For patients with malformed inner ears, MED-EL customizes electrode arrays based on specific anatomical needs, demonstrating a commitment to personalized treatment through collaboration with CI surgeons worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Special electrodes for demanding cochlear conditions. Dhanasingh, A., Hochmair, I.[2021]

Cochlear implants are now being offered to a broader range of individuals with severe to profound hearing loss, thanks to advancements in technology and new speech-coding strategies developed by MED-EL.

Research indicates that bilateral cochlear implantation and electric-acoustic stimulation can enhance hearing outcomes, and preliminary evaluations of a hybrid cochlear implant system that includes drug delivery show promising results for further improving these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MED-EL Cochlear implants: state of the art and a glimpse into the future. Hochmair, I., Nopp, P., Jolly, C., et al.[2023]

In a study involving 12 experienced cochlear implant users, the Rondo audio processor, when worn further behind the ear, did not significantly improve speech intelligibility in noise compared to the Opus 2 processor.

However, the Opus 2 showed a significantly better signal-to-noise ratio when noise came from behind, suggesting that the positioning of the audio processor can impact performance in noisy environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech Intelligibility in Noise With a Single-Unit Cochlear Implant Audio Processor. Wimmer, W., Caversaccio, M., Kompis, M.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932275/

Long-Term Outcomes Following Cochlear Implantation The purpose of this study was to evaluate the clinical and audiological outcomes in long-term cochlear implant (CI) users, focusing on hearing performance and ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P000025S129b.pdf

MED-EL Cochlear Implant System Device - accessdata.fda.gov Effectiveness outcomes included CNC Words in quiet (implant ear alone), AzBio Sentences in noise (implant ear alone), and AzBio Sentences in noise in the ...

3. medel.com medel.com/en-us/hearing-solutions/cochlear-implants/reliability

Reliable Hearing by Design: MED-EL Cochlear Implants SYNCHRONY 2 has one of the best cochlear implant reliability performance records on the market, with an overall CSR of 99.86% within six years.[1][2][3]. 99.86%

4. blog.medel.pro blog.medel.pro/audiology/cochlear-implantation-outcomes-in-adults-with-unilateral-deafness-speech-perception-tinnitus-sound-localization-and-quality-of-life/

Cochlear Implantation Outcomes in Adults With Unilateral ... Adults with unilateral deafness often see improvements in speech recognition, sound localization, tinnitus, and quality of life after CI.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12558452/

MED-EL hearing solution registry: An examination of the ... There is a significant gap in routine clinical data concerning cochlear implant (CI) users, particularly regarding real-world outcomes.

6. medel.pro medel.pro/resources/rs/reliability-safety/cochlear-implants

360° View of Cochlear Implant Safety and Reliability ... EL hearing implant meets the highest standards for quality, safety, and reliability. ... Long-term hearing preservation outcomes after cochlear implantation ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P000025S104B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) implantation and use of the MED-EL Cochlear Implant System: • Sudden losses of residual low-frequency hearing. • Total loss of residual hearing.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00747435?term=AREA%5BNCTIdSearch%5D(NCT00747435)&rank=1

Safety and Effectiveness of the MED-EL Electric-Acoustic ... Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years ...