Cochlear Implants for Unilateral Hearing Loss

No longer recruiting at 2 trial locations

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Med-El Corporation

Disqualifiers: Cognitive concern, Cochlear malformation, 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: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of cochlear implants for adults with hearing loss in one ear. Researchers aim to determine if these implants can improve hearing in the affected ear. The study seeks participants aged 65 or older with significant hearing loss in one ear and normal or nearly normal hearing in the other. Candidates should have also tried other hearing aids, such as CROS or bone conduction devices. As an unphased trial, this study offers a unique opportunity to contribute to the understanding and improvement of hearing solutions for others.

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 coordinators or your doctor.

What prior data suggests that the MED-EL Cochlear Implant System is safe for adults 65 years and older?

Research has shown that the MED-EL Cochlear Implant System is generally safe. In one study, about 15.9% of participants experienced temporary hearing loss. Some individuals felt dizzy or unsteady, with 9.1% reporting these symptoms. Tinnitus, a ringing or buzzing in the ears, was noted by 4.5% of users.

These effects are usually mild and temporary for most people. The MED-EL system has improved speech understanding and quality of life for those with hearing loss. While some temporary side effects may occur, many users find the benefits worthwhile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MED-EL Cochlear Implant System for unilateral hearing loss because it offers a new approach compared to traditional hearing aids or contralateral routing of signals (CROS) systems. Unlike these options, which simply amplify sound or redirect it to the better-hearing ear, cochlear implants directly stimulate the auditory nerve, potentially providing a more natural hearing experience. This can lead to improved sound localization and speech understanding in noisy environments, which are often challenging for those using conventional devices.

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

Research has shown that cochlear implants can help adults with hearing loss in one ear. Studies have found that these implants improve speech recognition, enabling better word comprehension. Users often find it easier to locate the source of sounds. Many experience reduced tinnitus, or ringing in the ears, and an overall improvement in quality of life. In this trial, participants will receive the MED-EL Cochlear Implant System, which has proven particularly effective in these areas, especially for those aged 65 and older with hearing loss in one ear. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 65 with single-sided deafness who have tried other hearing aids without success. They must have profound hearing loss in one ear and normal or near-normal hearing in the other, not have had long-term deafness, no recent sudden hearing loss, and no issues that would make surgery risky.

Inclusion Criteria

You have previously used a specific type of hearing aid as recommended by the investigator.

You have already used a hearing aid that suits your needs, as recommended by the researcher. You are able to speak and understand English fluently.

Your ability to recognize words in the ear that will receive an implant is 5% or less in a quiet environment.

Exclusion Criteria

I have an infection in my outer or middle ear.

I have a severe inner ear abnormality.

I have a health condition that makes surgery or anesthesia risky for me.

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

12 months

Regular visits at pre-operative, 6-month, and 12-month intervals

What Are the Treatments Tested in This Trial?

Interventions

• MED-EL Cochlear Implant System

Trial Overview

The study tests the safety and effectiveness of the MED-EL Cochlear Implant System in older adults with unilateral hearing loss. It aims to see if this implant can improve their ability to hear when traditional devices haven't worked well.

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 of 808 profoundly or totally deaf patients who underwent cochlear implantation, a minimally invasive surgical approach was found to be safe, with no complications like skin flap problems reported.

The minimally invasive technique not only did not increase surgical risks but also provided cosmetic and psychological benefits, particularly for children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four years' experience with the minimally invasive surgical approach in cochlear implant surgery. Mack, KF., Heermann, R., Issing, PR., et al.[2014]

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]

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]

Cochlear implants (CIs) significantly improve quality of life for patients with unilateral hearing loss (UHL), with benefits observed as early as one month after activation, based on assessments from 20 subjects over the first year of use.

Patients with UHL reported less difficulty in hearing compared to those with bilateral hearing loss, indicating that having normal hearing in one ear may enhance the perceived benefits of CI use, particularly in areas like speech perception in noise and spatial hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss. Dillon, MT., Buss, E., Rooth, MA., et al.[2022]

Cochlear implants can significantly improve speech understanding in noisy environments for individuals with unilateral hearing loss, as demonstrated in a case report involving four men aged 48 to 57.

This case report suggests that unilateral cochlear implantation may be a viable treatment option for patients with unilateral hearing loss, expanding the criteria for cochlear implant candidates and encouraging further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary speech recognition results after cochlear implantation in patients with unilateral hearing loss: a case series. Stelzig, Y., Jacob, R., Mueller, J.[2021]

A study involving 30 patients with Mondini's deformity demonstrated that a 31 mm straight electrode array can be safely and effectively fully inserted using round window insertion during cochlear implantation, with no resistance encountered during the procedure.

No immediate or delayed post-operative complications were reported in any of the patients over an average follow-up period of 6 to 36 months, indicating a high safety profile for this implantation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implantation in Mondini's deformity: could the straight electrode array with length of 31 mm be fully inserted? Sun, JQ., Sun, JW., Hou, XY.[2018]

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]

Cochlear implantation in patients with single-sided deafness (SSD) shows potential benefits for improving speech discrimination, sound localization, and tinnitus suppression, based on a systematic review of eleven studies.

However, the current evidence is not strong enough, as most studies lack high-quality data, indicating a need for larger and more rigorous studies to better understand the true benefits of cochlear implants for SSD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear Implantation and Single-sided Deafness: A Systematic Review of the Literature. Cabral Junior, F., Pinna, MH., Alves, RD., et al.[2020]

The TEMPO+ speech processor, launched by MED-EL in 1999, has been shown to improve speech perception and sound quality, making it effective for cochlear implant users.

A survey of 185 users indicated high satisfaction with the TEMPO+, particularly among children, with one third of respondents under the age of 10, demonstrating its suitability for young users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handling of the TEMPO+ behind-the-ear speech processor by MED-EL cochlear implant users. Anderson, I., Schmidt, M., Buchreiter, T., et al.[2017]

Unilateral cochlear implantation is more cost-effective in improving quality of life for adults with profound hearing loss compared to bilateral implantation, with cost-utility ratios indicating greater benefits for unilateral procedures.

The study involved 70 normal-hearing volunteers and 202 patients, showing that while bilateral implantation offers some additional quality of life benefits, the cost per quality-adjusted life-year gained is significantly higher than for unilateral implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cost-utility scenario analysis of bilateral cochlear implantation. Summerfield, AQ., Marshall, DH., Barton, GR., et al.[2022]

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]

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]

Bilateral cochlear implantation provides significant hearing benefits over unilateral cochlear implantation, particularly in understanding speech in noisy environments.

In this study involving 15 patients (both children and adults), speech perception tests confirmed that those with bilateral implants performed better than those with a single implant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Our experience with bilateral cochlear implantation]. Carmel, E., Taitelbaum-Swead, R., Migirov, L., et al.[2008]

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]

Citations

1.

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.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10426784/

Two-Year Outcomes of Cochlear Implant Use for Children ...

This study investigated performance over 24 months of CI use in young children with SSD as compared to the better hearing ear alone and to children with ...

3.

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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11087191/

Auditory Outcomes Following Cochlear Implantation in ...

The remaining 3 patients (7.9%) had residual low-frequency hearing loss but poor thresholds in remaining frequencies with poor word ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04506853

Single-Sided Deafness and Asymmetric Hearing Loss

The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with ...

6.

medel.com

medel.com/en-us/hearing-solutions/cochlear-implants/synchrony2

SYNCHRONY 2 Cochlear Implant

Experience the best sound quality, proven reliability, outstanding MRI safety*****, and a lifetime of better hearing with the SYNCHRONY 2 cochlear implant.