Cochlear Implants for Hearing Loss

(ACE Trial)

Recruiting at 9 trial locations

Overseen By Lavin Entwisle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Pregnancy, Cochlear implant, 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: 8

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

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 coordinator or your doctor.

What data supports the effectiveness of the treatment Cochlear Implantation for hearing loss?

Cochlear implants significantly improve hearing in patients with severe to profound hearing loss, often outperforming conventional hearing aids. They enhance word recognition and lipreading abilities, and improve quality of life, although additional auditory training may be needed to maximize benefits. ^{1 2 3 4 5}

Is cochlear implantation generally safe for humans?

Cochlear implants have been used in over 150,000 people worldwide, including young children, and while device failure is a risk, they are generally considered safe. A study on the SONATATI 100 cochlear implant also supports its safety in both adults and children. ^{6 7 8 9 10}

How is cochlear implantation different from other treatments for hearing loss?

Cochlear implantation is unique because it directly stimulates the hearing nerve with electrical signals, bypassing damaged hair cells in the ear, unlike hearing aids that simply amplify sound. This makes it particularly beneficial for individuals with severe to profound hearing loss who do not benefit from traditional hearing aids. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for adults with bilateral sensorineural hearing loss who don't currently qualify for cochlear implants under FDA guidelines. Participants will be assessed over seven visits after receiving the implant.

Inclusion Criteria

I am 18 years old or older.

Meets audiometric criteria for the non-implanted contralateral ear: clinically established SNHL with a four frequency PTA at 500, 1000, 2000, & 4000 Hz of >30 dB HL

I have severe hearing loss and struggle to understand words even with a hearing aid.

Exclusion Criteria

Pregnant or breastfeeding women

Meets current indications on audiometric thresholds for traditional adult CI candidates

I do not have a cochlear nerve or my cochlea is undeveloped.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cochlear Implantation

Participants will be implanted with a commercially approved Cochlear™ Nucleus® implant

1 day

1 visit (in-person)

Post-implantation Assessment

Participants complete speech perception assessments and questionnaires over the course of seven visits

6 months

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• Cochlear Implantation

Trial Overview The study is testing the Cochlear™ Nucleus® System to see if it's safe and works well in improving hearing for those who have significant hearing loss but aren't eligible for current treatments.

Participant Groups

Group I: Cochlear™ Nucleus® System Experimental Treatment 1 Intervention

Participants will be implanted with a commercially approved Cochlear™ Nucleus® implant.

Cochlear Implantation is already approved in United States, European Union for the following indications:

Approved in United States as Cochlear Implant for:

• Severe to profound sensorineural hearing loss in both ears
• Moderate to profound sensorineural hearing loss in both ears with limited benefit from amplification
• Single-sided deafness/unilateral hearing loss (SSD/UHL)

Approved in European Union as Cochlear Implant for:

• Severe to profound sensorineural hearing loss in both ears
• Moderate to profound sensorineural hearing loss in both ears with limited benefit from amplification

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

Althea Anagnostopoulos Harrington

Collaborator

Trials

2

Recruited

110+

MV Clinical Research, LLC

Collaborator

Trials

2

Recruited

110+

LWB Consulting

Collaborator

Trials

2

Recruited

110+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Findings from Research

Cochlear implants significantly improve hearing in profoundly hearing-impaired patients, with performance in a study of 63 patients showing a wide range of outcomes, including up to 62% correct word recognition and 98% enhancement in lipreading.

Prelingually deaf children benefit from cochlear implants but take longer to show improvements compared to postlingually deaf individuals, highlighting the need for tailored rehabilitation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What can we learn about hearing aids from cochlear implants? Tyler, RS.[2019]

Cochlear implants (CIs) provide significantly better hearing improvement for patients with severe to profound hearing loss compared to conventional hearing aids, making them a more effective treatment option.

The MED-EL multichannel CI system has shown high reliability, with no technical failures reported over a 5-year observation period, highlighting the advancements in implant technology and design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. Baumann, U., Stöver, T., Weißgerber, T.[2022]

Cochlear implants, which send electrical impulses directly to the cochlear nerve, are a significant advancement for patients with severe hearing loss who cannot benefit from traditional hearing aids, and they are now being used in pediatric patients as well.

A multidisciplinary team approach is crucial for the successful implantation and follow-up care of cochlear implants, with 29 patients having received implants using a preferred multi-channel intracochlear system, demonstrating a positive impact on their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implants in children]. Garabedian, EN., Moatti, L., Roger, G., et al.[2006]

Cochlear implants significantly improve auditory performance and speech production compared to hearing aids, as shown in a study of 84 patients, highlighting their effectiveness in enhancing quality of life for children with severe to profound hearing loss.

Younger implantation age is associated with better health-related quality of life outcomes, but even older children can achieve good results with proper selection and training, indicating that cochlear implants can be beneficial across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life in cochlear implanted patients in Romania. Necula, V., Cosgarea, M., Necula, SE.[2015]

Cochlear implants have advanced significantly, but some patients still struggle with speech recognition, especially in noisy environments, and music appreciation remains a challenge.

Targeted auditory training can significantly enhance speech recognition for both poorly performing and high-performing cochlear implant users, suggesting that additional rehabilitation is essential to fully benefit from cochlear implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing cochlear implant patients' performance with advanced speech training procedures. Fu, QJ., Galvin, JJ.[2021]

In a study of 113 patients with Advanced Bionics Ultra cochlear implants, 17.7% experienced device failure, primarily in children, highlighting the need for ongoing monitoring of at-risk devices.

After revision surgeries, patients generally maintained stable auditory performance, indicating that revision procedures are effective and safe, with most patients opting to stay with the same manufacturer for their new devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. Winchester, A., Kay-Rivest, E., Friedmann, DR., et al.[2023]

In a study of 52 patients with recalled Advanced Bionics cochlear implants, significant hearing performance degradation was observed, particularly linked to issues with the basal-most electrodes of the device.

After revision surgery, patients showed a rapid recovery in hearing performance, reaching peak levels much faster than after their initial implantation, indicating effective outcomes from reimplantation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voluntary Field Recall of Advanced Bionics HiRes Cochlear Implants: A Single-Institution Experience. McHugh, CI., Swedenborg, BK., Chen, JX., et al.[2023]

A study of 3,417 cochlear implant recipients over 23 years revealed that the cumulative survival rates (CSRs) for cochlear implants vary significantly between different models and brands, particularly at the 6-year mark.

Common causes of device failure include impact, electronic dysfunction, and leakage, but explant-reimplant procedures are considered safe and effective for addressing these failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees. Battmer, RD., Linz, B., Lenarz, T.[2022]

The SONATATI(100) cochlear implant has been shown to be safe and effective in a study involving 50 patients, with no unexpected adverse events reported during medium-term use.

The implantation of the SONATATI(100) cochlear implant is less traumatic due to smaller incisions and less drilling required, making it a suitable option for both adults and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The MED-EL SONATATI 100 cochlear implant: an evaluation of its safety in adults and children. Mueller, J., Baumgartner, WD., Godey, B., et al.[2013]

A study analyzing adverse event reports for cochlear implants found that most incidents involved patient injury (16,736 cases) and device malfunction (10,760 cases), highlighting areas for potential safety improvements.

Using machine learning algorithms, researchers achieved high prediction accuracy (up to 88.6%) in identifying the cochlear implant manufacturer and type of adverse event based on the descriptions, suggesting that data analysis can enhance understanding of device performance and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. Crowson, MG., Hamour, A., Lin, V., et al.[2021]

Cochlear implants are effective electronic devices that significantly improve hearing quality for individuals with severe to profound deafness, including both children and adults.

Advancements in surgical techniques and device technology have broadened the criteria for who can receive cochlear implants, allowing more people to benefit from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implants in children. Balkany, TJ., Hodges, A., Miyamoto, RT., et al.[2022]

Cochlear implants are advanced devices that electrically stimulate the hearing nerve, making them suitable for individuals with severe to profound hearing loss who do not benefit from hearing aids.

These implants replace the function of damaged hair cells in the cochlea, leading to improved hearing and communication abilities for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implants]. Demanez, L., Renglet, T., Bernard, C., et al.[2015]

Cochlear implants are effective electronic devices that help restore hearing in individuals who have lost their hair cells by directly stimulating the spiral ganglion cells of the cochlear nerve.

The article provides essential information for head and neck surgeons regarding the necessary imaging protocols and potential anatomical anomalies to consider before performing cochlear implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implant assessment: imaging issues. Marsot-Dupuch, K., Meyer, B.[2019]

Cochlear implants and auditory brainstem implants provide patients with profound hearing loss the ability to perceive sound through electrical stimulation of the auditory pathway, which is crucial for communication.

Cochlear implants are effective for those with inner ear disorders and a functioning hearing nerve, while auditory brainstem implants are designed for patients with hearing nerve defects, highlighting the importance of thorough preoperative evaluations to determine the appropriate device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implants and electrical brainstem stimulation in sensorineural hearing loss. Laszig, R., Aschendorff, A.[2019]

In a study of 9 children with auditory brainstem implants (ABIs) at Shaare-Zedek Medical Center, 6 had previously unsuccessful cochlear implants due to deficient auditory nerves, highlighting ABI as a crucial option for those who cannot benefit from traditional cochlear implants.

While the functional auditory outcomes for ABI recipients were generally lower than those for cochlear implant users, some children achieved significant benefits, including one child who attained open-set speech perception, indicating that ABIs can provide auditory awareness in cases where cochlear implants are not viable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[AUDITORY BRAINSTEM IMPLANTS (ABI) IN CHILDREN: CASE SERIES IN SHAARE ZEDEK MEDICAL CENTER]. Perez, R., Sichel, JY., Salem, R., et al.[2023]

References

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

What can we learn about hearing aids from cochlear implants? [2019]

2. England pubmed.ncbi.nlm.nih.gov

Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Cochlear implants in children]. [2006]

4. Ireland pubmed.ncbi.nlm.nih.gov

Health-related quality of life in cochlear implanted patients in Romania. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Maximizing cochlear implant patients' performance with advanced speech training procedures. [2021]

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

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. [2023]

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

Voluntary Field Recall of Advanced Bionics HiRes Cochlear Implants: A Single-Institution Experience. [2023]

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

A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees. [2022]

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

The MED-EL SONATATI 100 cochlear implant: an evaluation of its safety in adults and children. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. [2021]

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

Cochlear implants in children. [2022]

12. Belgium pubmed.ncbi.nlm.nih.gov

[Cochlear implants]. [2015]

13. Ireland pubmed.ncbi.nlm.nih.gov

Cochlear implant assessment: imaging issues. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Cochlear implants and electrical brainstem stimulation in sensorineural hearing loss. [2019]

15. Israel pubmed.ncbi.nlm.nih.gov

[AUDITORY BRAINSTEM IMPLANTS (ABI) IN CHILDREN: CASE SERIES IN SHAARE ZEDEK MEDICAL CENTER]. [2023]