Cochlear Implant for Unilateral Hearing Loss Post-Surgery

Overseen By William Riggs, AuD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Bilateral Meniere's, Bilateral schwannomas, 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

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of cochlear implants for individuals who lose hearing in one ear after surgery for a non-cancerous tumor on the hearing nerve (vestibular schwannoma) or a procedure for Meniere's disease. After surgery, patients will receive a cochlear implant in the affected ear to aid in hearing sounds and understanding speech. The study aims to enhance sound detection and speech comprehension in noisy environments. Ideal participants are those diagnosed with either condition who have scheduled surgery and speak English to complete speech tasks. As an unphased trial, this study offers a unique opportunity to contribute to understanding the benefits of cochlear implants for specific hearing loss conditions.

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 this cochlear implant is safe for individuals with unilateral hearing loss?

Earlier studies have shown that cochlear implants are safe for individuals with hearing loss in one ear, including those with vestibular schwannoma and Meniere's disease. Research indicates that most patients experience improved hearing with these implants. Additionally, studies suggest that cochlear implants can significantly reduce tinnitus (ringing in the ears) for individuals with vestibular schwannoma.

While cochlear implant surgery carries some risks, such as device malfunction or irritation at the surgery site, these are generally well-understood and managed. The FDA has already approved these implants for individuals with hearing loss in both ears, supporting their safety. Overall, existing evidence suggests that cochlear implants are well-tolerated and can be a safe option for improving hearing in individuals with hearing loss in one ear. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cochlear implants for unilateral hearing loss because they offer a new way to restore hearing for patients who have undergone specific ear surgeries. Unlike standard treatments that might focus on rehabilitative therapies or hearing aids, this approach directly stimulates the auditory nerve, potentially providing clearer and more natural sound perception. Additionally, by integrating the cochlear implant during surgery for conditions like Meniere's disease or vestibular schwannoma, patients may experience an immediate improvement in hearing post-operation. This innovative use of cochlear implants could significantly enhance quality of life for individuals affected by these conditions.

What evidence suggests that a cochlear implant is effective for unilateral hearing loss?

Research shows that cochlear implants can help individuals with single-sided deafness. One study found that people with severe hearing loss in one ear who received cochlear implants improved in hearing sounds and understanding speech. In this trial, participants diagnosed with Meniere's disease undergoing labyrinthectomy or those with vestibular schwannoma undergoing surgical excision via the translabyrinthine approach will receive a cochlear implant during surgery. Previous studies on patients with vestibular schwannoma, a non-cancerous tumor affecting hearing, found mixed but hopeful results with cochlear implants. While outcomes can differ from those with hearing loss in both ears, some patients experienced significant improvements. These findings suggest that cochlear implants might benefit those with hearing loss on one side after certain surgeries. ^{1 5 6 7 8}

Who Is on the Research Team?

Oliver Adunka, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Implant

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.

How Is the Trial Designed?

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.

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

Approved in United States as Cochlear Implant for:

• Single-sided deafness (SSD) in children aged 5 years and older
• Severe to profound sensorineural hearing loss in both ears

Approved in European Union as Cochlear Implant for:

• Severe to profound sensorineural hearing loss in both ears
• Single-sided deafness (SSD) in children and adults

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+

Published Research Related to This Trial

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]

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]

Cochlear implants are now approved for patients with severe to profound unilateral hearing loss, expanding candidacy beyond the previous requirement of bilateral profound loss, which enhances accessibility for more patients.

Advancements in surgical techniques, such as the use of short electrode arrays for shallow insertion, allow patients to retain low-frequency hearing while benefiting from cochlear implants for high frequencies, improving both safety and efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New criteria of indication and selection of patients to cochlear implant. Sampaio, AL., Araújo, MF., Oliveira, CA.[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]

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 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]

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]

Cochlear implants can significantly improve sound localization and speech understanding in patients with unilateral deafness, even when their better ear has some hearing loss, as demonstrated in a study of three patients.

The findings suggest that the use of cochlear implants is expanding to include more diverse cases of hearing impairment, indicating their potential effectiveness for patients with unique hearing challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear Implants in Patients with Fluctuant or Progressive Hearing Loss on the Better Ear. Mangabeira-Albernaz, PL., Malerbi, AFDS.[2021]

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]

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]

Out of 250 patients who underwent cochlear implant surgery, 13.2% experienced postoperative complications, with 8.0% having minor issues and 5.2% facing major complications, indicating that while the surgery is generally safe, complications can occur.

The most common complications included hematomas, device failures, and infections, highlighting the importance of skilled surgical practice and ongoing training for surgeons to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative complications in implanted patients in the Cochlear Implant Program of Rio Grande do Norte-Brazil. Lima Júnior, LR., Rodrigues Júnior, Fde A., Calhau, CM., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3866094/

Outcomes following cochlear implantation for patients with ... Compare pre and postoperative performance in patients undergoing cochlear implantation (CI) for unilateral severe-to-profound sensorineural hearing loss ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02532972

Cochlear Implantation for Treatment of Single-sided ... This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided ...

3. theajo.com theajo.com/article/view/4961/html

Cochlear implant outcomes associated with different ... Cochlear implant outcomes associated with different treatments of vestibular schwannoma.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1808869425000060

Cochlear implantation in vestibular schwannoma Cochlear implantation is a solution for some patients with vestibular schwannoma. Audiological outcomes are variable, but worse than conventional CI candidates.

5. journals.lww.com journals.lww.com/otology-neurotology/toc/2025/07000

July 2025 - Volume 46 - Issue 6 : Otology & Neurotology Evaluating the Cost-Effectiveness of Unilateral Cochlear Implants Versus Hearing Aids in Older Adults in Japan ... Vestibular Schwannoma With Hearing Preservation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9524396/

Cochlear Implantation for Patients with a Vestibular ... The tinnitus burden is significantly reduced by cochlear implantation in individuals with a vestibular schwannoma. This agrees with findings for other ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11564253/

Cochlear implantation in patients with inner ear ... The results from this systematic review study show that hearing loss in most patients with IES can be successfully rehabilitated with cochlear ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02203305

Cochlear Implantation in Cases of Single-Sided Deafness Medical condition considered a contraindication to undergoing cochlear implantation; Conductive hearing loss in either ear; Compromised auditory nerve, ...