Cochlear Implants for Unilateral Hearing Loss

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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.

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 data supports the effectiveness of the treatment MED-EL Cochlear Implant System for unilateral hearing loss?

Research shows that cochlear implants can improve quality of life for people with hearing loss in one ear by enhancing their ability to understand speech and locate sounds, especially in noisy environments. ^{1 2 3 4 5}

Is the MED-EL Cochlear Implant System safe for humans?

Research shows that the MED-EL Cochlear Implant System, used in various forms, is generally safe for humans. Studies have demonstrated that the surgical techniques used for implantation do not increase surgical risk and are beneficial both cosmetically and psychologically, especially for children. ^{6 7 8 9 10}

What makes the MED-EL Cochlear Implant System unique for treating unilateral hearing loss?

The MED-EL Cochlear Implant System is unique for treating unilateral hearing loss because it is one of the first to show benefits in speech understanding in noisy environments for patients with hearing loss in one ear, while the other ear has normal hearing. This system also offers custom-designed electrode arrays to match individual cochlear anatomy, enhancing its effectiveness. ^{4 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Utility of bilateral acoustic hearing in combination with electrical stimulation provided by the cochlear implant. [2017]

2. Israel pubmed.ncbi.nlm.nih.gov

[Our experience with bilateral cochlear implantation]. [2008]

3. Brazil pubmed.ncbi.nlm.nih.gov

Cochlear Implantation and Single-sided Deafness: A Systematic Review of the Literature. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Cochlear implantation in Mondini's deformity: could the straight electrode array with length of 31 mm be fully inserted? [2018]

7. England pubmed.ncbi.nlm.nih.gov

Handling of the TEMPO+ behind-the-ear speech processor by MED-EL cochlear implant users. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Four years' experience with the minimally invasive surgical approach in cochlear implant surgery. [2014]

9. England pubmed.ncbi.nlm.nih.gov

U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

MED-EL Combi40+ cochlear implantation in adults. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Preliminary speech recognition results after cochlear implantation in patients with unilateral hearing loss: a case series. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

A cost-utility scenario analysis of bilateral cochlear implantation. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Special electrodes for demanding cochlear conditions. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

MED-EL Cochlear implants: state of the art and a glimpse into the future. [2023]