Cochlear Implant for Unilateral Hearing Loss Post-Surgery

Overseen By Meghan Hiss, AuD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University

Disqualifiers: Bilateral Meniere's, Bilateral schwannomas, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.

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 Cochlear Implant for Unilateral Hearing Loss Post-Surgery?

Research shows that cochlear implants can improve speech understanding in noisy environments and help with sound localization for people with unilateral hearing loss. They may also reduce tinnitus (ringing in the ears) and have been shown to be beneficial in cases of severe hearing loss on one side. ^{1 2 3 4 5}

Is cochlear implantation generally safe for humans?

Cochlear implantation is generally considered a safe procedure with a low rate of complications, although issues like device failure and the need for reoperation can occur. Advances in surgical techniques and device design have improved safety over time. ^{6 7 8 9 10}

How is the cochlear implant treatment unique for unilateral hearing loss?

Cochlear implants for unilateral hearing loss are unique because they directly stimulate the ear with sound signals, improving the ability to locate sounds and understand speech in noisy environments, which is not typically achieved with other treatments. This approach is relatively new for single-sided deafness and can also help reduce tinnitus (ringing in the ears). ^{2 11 12 13 14}

Research Team

Oliver Adunka, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for English-speaking adults under 70 with single-sided hearing loss due to a small vestibular schwannoma (VS) or Meniere's disease, where the auditory nerve can be preserved during surgery. It excludes those with large VS over 2 cm, bilateral conditions, middle ear disease, cochlear ossification/fibrosis, and refusal of pneumococcal vaccine.

Inclusion Criteria

I have been diagnosed with vestibular schwannoma or Meniere's disease by a doctor.

I am scheduled for surgery to remove a brain tumor via the ear or to have part of my inner ear removed.

My surgery will not damage the nerve related to hearing.

Exclusion Criteria

I cannot have surgery due to health reasons.

You have a condition in your ear that makes it unsuitable for a cochlear implant.

My vestibular schwannoma is larger than 2 cm.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Implantation

Participants undergo surgery to remove a vestibular schwannoma or have a labyrinthectomy, followed by cochlear implant insertion

1 day

1 visit (in-person)

Processor Fitting

Approximately 4 weeks after surgery, participants are fitted with an external speech processor to stimulate the cochlear implant

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, completing questionnaires and undergoing hearing tests at specified intervals

12 months

6 visits (in-person) at 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months

Treatment Details

Interventions

• Cochlear Implant (Prosthesis)

Trial Overview The study tests if it's safe and effective to use a cochlear implant in patients who become deaf on one side after VS removal or labyrinthectomy. After surgery, an implant is inserted and later connected to an external processor. Hearing and quality of life are assessed over a year.

Participant Groups

Group I: Meniere's Disease/Vestibular Schwannoma Experimental Treatment 1 Intervention

Individuals diagnosed with Meniere's disease and undergoing labyrinthectomy or diagnosed with vestibular schwannoma and undergoing surgical excision via translabyrinthine approach for treatment will receive cochlear implant at the time of surgery.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Advanced Bionics

Industry Sponsor

Trials

17

Recruited

500+

Findings from Research

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]

Cochlear implantation (CI) can significantly enhance binaural hearing for patients with severe-to-profound unilateral sensorineural hearing loss, improving sound localization and speech recognition in noisy environments.

CI may also provide some relief from tinnitus, but further research is needed to understand its long-term effects and to refine patient selection criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research progress on cochlear implantation in patients with unilateral deafness]. Shi, Y., Li, YX.[2018]

The successful implantation of the Digisonic SP® Binaural Neurelec device in Brazil marks a significant advancement in cochlear implant technology, particularly for bilateral hearing, which offers enhanced benefits like improved sound localization and binaural summation.

This device not only aims to reduce the costs associated with cochlear implants, making them more accessible, but also utilizes a minimally invasive surgical approach, potentially lowering the risks for patients during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digisonic SP® Binaural cochlear implant: the coronal tunneled approach. Carvalho, GM., Guimarães, AC., Macedo, IS., et al.[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 (CIs) are effective for severe hearing loss, but complications like implant exposure can occur; this study reviewed three cases requiring surgical intervention for exposed CIs.

Using local scalp flaps for reconstruction after CI exposure proved to be a reliable method, resulting in successful recovery and functional implants for all patients over a 1-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvaging Exposed Cochlear Implants. Arab, K., Altamimi, L., Al-Otaibi, H., et al.[2022]

In a retrospective study of 246 cochlear implants over 11 years, the overall complication rate was low at 11.38%, with device failure being the most common issue, occurring in 6.5% of cases, particularly in children under 10 years old.

While most complications were minor and easily resolved, the prevalence of device failure highlights the need for ongoing research to identify causes and improve the reliability of cochlear implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implant complications and failures]. Achiques, MT., Morant, A., Muñoz, N., et al.[2022]

Cochlear implantation is a safe procedure with a low overall complication rate of 12.2%, and no cases of postoperative meningitis or facial nerve palsy were reported, indicating a favorable safety profile for both adults and children.

The study analyzed 342 operations over a 9-year period, revealing that while the majority of patients experienced no major issues, there is a notable risk of device failure, particularly higher in children (13.92%) compared to adults (7.07%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical considerations in cochlear implantation in children and adults: a review of 342 cases in Vienna. Arnoldner, C., Baumgartner, WD., Gstoettner, W., et al.[2019]

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]

Using a cochlear implant in one ear along with a hearing aid in the opposite ear (bimodal hearing) significantly improves speech recognition and localization compared to using either device alone, based on a study of 19 adult cochlear implant recipients.

Participants reported a strong preference for bimodal stimulation, highlighting its benefits for understanding speech in noisy environments and effectively locating sound sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognition and localization of speech by adult cochlear implant recipients wearing a digital hearing aid in the nonimplanted ear (bimodal hearing). Potts, LG., Skinner, MW., Litovsky, RA., et al.[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]

Bilateral cochlear implantation is recommended for children with severe to profound hearing loss, as it provides better hearing outcomes compared to unilateral implantation, especially in noisy environments.

The timing of cochlear implantation is crucial; shorter intervals between hearing loss and surgery, as well as between sequential implantations, lead to improved hearing results, highlighting the importance of early intervention and effective rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bilateral cochlear implantation]. Kronenberg, J., Migirov, L., Taitelbaum-Swead, R., et al.[2010]

References

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

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

2. China pubmed.ncbi.nlm.nih.gov

[Research progress on cochlear implantation in patients with unilateral deafness]. [2018]

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

Cochlear Implants in Patients with Fluctuant or Progressive Hearing Loss on the Better Ear. [2021]

4. Brazil pubmed.ncbi.nlm.nih.gov

Digisonic SP® Binaural cochlear implant: the coronal tunneled approach. [2022]

5. France pubmed.ncbi.nlm.nih.gov

[Cochlear implants in children]. [2006]

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

Salvaging Exposed Cochlear Implants. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[Cochlear implant complications and failures]. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Postoperative complications in implanted patients in the Cochlear Implant Program of Rio Grande do Norte-Brazil. [2022]

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

New criteria of indication and selection of patients to cochlear implant. [2022]

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

Surgical considerations in cochlear implantation in children and adults: a review of 342 cases in Vienna. [2019]

11. Israel pubmed.ncbi.nlm.nih.gov

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

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

Recognition and localization of speech by adult cochlear implant recipients wearing a digital hearing aid in the nonimplanted ear (bimodal hearing). [2021]

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

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

14. Israel pubmed.ncbi.nlm.nih.gov

[Bilateral cochlear implantation]. [2010]