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

Trial Summary

What is the purpose of this trial?

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 single-sided deafness and asymmetric hearing loss.

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

Research shows that cochlear implants, like the MED-EL system, can improve hearing and speech understanding. For example, studies have found that users of similar devices, such as the Rondo, experience better speech intelligibility in noisy environments, and the Combi 40+ implant has shown significant improvements in hearing and speech discrimination. ^{1 2 3 4 5}

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

The MED-EL Combi40+ cochlear implant system has been used in adults for severe to profound hearing loss and was approved in the United States in 2001, indicating it has undergone safety evaluations for human use. ^{4 6 7 8 9}

What makes the MED-EL Cochlear Implant System unique compared to other treatments for hearing loss?

The MED-EL Cochlear Implant System is unique because it offers a variety of electrode array designs to match different cochlear anatomies, including custom designs for special needs, and it incorporates advanced signal processing strategies to improve speech understanding and music enjoyment. Additionally, it features a combined speech processor for electric acoustic stimulation, which benefits users with some residual hearing. ^{1 8 9 10 11}

Eligibility Criteria

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.

Fluent in English

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

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

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

Treatment Details

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.

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

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Speech Intelligibility in Noise With a Single-Unit Cochlear Implant Audio Processor. [2018]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cochlear implantation with implant Combi 40+ produced by MED-El]. [2006]

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Validation of minimally invasive, image-guided cochlear implantation using Advanced Bionics, Cochlear, and Medel electrodes in a cadaver model. [2021]

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

Special electrodes for demanding cochlear conditions. [2021]

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

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

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

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

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

Signal processing & audio processors. [2021]