Cochlear Implant for Single-Sided Deafness

Recruiting in Palo Alto (17 mi)

Overseen by Lisa Park, AuD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Conductive hearing loss, Cochlear nerve deficiency, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: * Undergo cochlear implantation * Wear their cochlear implant processor whenever they are awake. * Participate in traditional hearing tests * Participate in traditional hearing testing * Participate in localization testing * Participate in hearing in noise testing * Participate in word recognition testing * Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your child's doctor.

What data supports the effectiveness of the treatment Cochlear Implant for Single-Sided Deafness?

Research shows that cochlear implants can improve speech understanding in noisy environments and help with sound localization for people with single-sided deafness. Many users report satisfaction and perceive benefits in various listening situations, indicating that cochlear implants can be a beneficial treatment option for this condition. ^{1 2 3 4 5}

Is the cochlear implant generally safe for humans?

Research shows that cochlear implants, including the HiRes Ultra series, have been used in humans, but there have been instances of device failure leading to recalls. However, surgical and auditory outcomes after revision have been reported, indicating ongoing monitoring and management of safety issues. ^{6 7 8 9 10}

How is the cochlear implant treatment unique for single-sided deafness?

Cochlear implants for single-sided deafness are unique because they restore hearing in the deaf ear, improving sound localization and speech understanding in noisy environments, and can also help reduce tinnitus (ringing in the ears). Unlike other treatments like CROS hearing aids, which only route sound from the deaf ear to the hearing ear, cochlear implants provide true binaural (two-eared) hearing. ^{1 3 11 12 13}

Eligibility Criteria

This trial is for infants and toddlers aged 7 months to under 3 years with severe-to-profound hearing loss in one ear, which isn't getting better with hearing aids. They should be generally healthy, have normal development and cognition, and their families must speak English at home. Kids can't join if they have certain inner ear abnormalities, lack of cochlear nerve, or conditions that make surgery risky.

Inclusion Criteria

Your cochlear nerve looks normal in the images taken by the doctor.

You have severe hearing loss in one ear that started before you turned 2 years old.

Parents have practical expectations.

Exclusion Criteria

I have a problem with the nerve that connects my ear to my brain.

I have a history of severe ear infections or a condition that makes anesthesia risky.

My inner ear has hardening that prevents implant surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cochlear implantation and receive programming of the device

Surgery and initial programming

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness, including auditory development and device-related adverse events

5 years

Regular visits for auditory testing and device monitoring

Testing and Evaluation

Participants undergo various auditory and cognitive tests, including localization, hearing in noise, and word recognition testing

Ongoing during follow-up

Treatment Details

Interventions

• Cochlear Implant (Prosthesis)

Trial Overview The study tests the safety and effectiveness of cochlear implants in young children with single-sided deafness. It involves implanting a device into the child's ear and monitoring their hearing abilities up until age five compared to kids without implants or those with normal hearing.

Participant Groups

Group I: Study Group Experimental Treatment 1 Intervention

This group of children with single-sided deafness will receive a cochlear implant.

Group II: Typical Hearing Control Group (THCG) Active Control 1 Intervention

This group of five-year-old children will have typical hearing in both ears.

Group III: Single-Sided Deafness Control Group (SSDCG) Active Control 1 Intervention

This group of five-year-old children will have single-sided deafness and no cochlear implant.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Children's Cochlear Implant Center at UNC Durham, NC

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill Lead Sponsor

Med-El Corporation Industry Sponsor

References

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

Cochlear implantation in recipients with single-sided deafness: Audiological performance. [2022] To examine the auditory benefit of cochlear implants (CI) in patients with single-sided deafness (SSD).

2. Germany pubmed.ncbi.nlm.nih.gov

[Unilateral deafness and cochlear implantation: audiological diagnostic evaluation and outcomes]. [2021] Cochlear implantation (CI) is a new form of treatment in the rehabilitation of single-sided deafness. The patient requires thorough initial examination and a full explanation of alternative treatment options prior to determining the indication for CI treatment. To date, we have treated 28 patients with CI, of whom data are available for 11 after 12 months. We examined speech comprehension in background noise and localisation ability 12 months after CI implantation compared to conventional CROS (contralateral routing of signal) hearing aids, BAHA (bone-anchored hearing aid) and hearing in untreated patients. In addition, we determined the subjective handicap (HHIE, hearing handicap inventory for the elderly) and the subjective success (IOI-HA, international outcome inventory for hearing aids; SSQ, spatial and qualities of hearing scale) of each treatment option. After 12 months' experience, the results show a significantly better localisation ability and an improvement in speech comprehension in background noise with CI than with the other treatment options. Subjective results also show a clear benefit with CI. Careful patient selection is a decisive factor for successful treatment of this patient group. Under these conditions, CI is a treatment option with which significant improvement in speech comprehension and localization ability in single-sided deafness is possible.

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

Cochlear implantation leading to successful stapedectomy in the contralateral only-hearing ear. [2016] Cochlear implants have recently begun to be offered to patients with single-sided deafness (SSD). Implantation in these patients has led to good results in suppressing ipsilateral tinnitus and in providing audiologic benefits in terms of speech perception in noise and localization. One previously unreported benefit of cochlear implantation in patients with SSD is the restoration of functional hearing in the previously deaf ear, which may allow for surgical opportunities in the contralateral hearing ear. We report a case in which cochlear implantation in the deaf left ear of a 50-year-old man allowed for surgical intervention in the previously only-hearing right ear, which in turn led to the restoration of normal middle ear function. Further studies may be warranted to consider the surgical candidacy of the contralateral only-hearing ear as another potential indication for cochlear implantation in patients with SSD.

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

Single-Sided Deafness: Emotional and Social Handicap, Impact on Health Status and Quality of Life, Functional Hearing, and the Effects of Cochlear Implantation. [2023] To evaluate the functional and subjective outcomes in individuals with single-sided deafness (SSD) treated with a cochlear implant (CI).

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

Speech intelligibility and subjective benefit in single-sided deaf adults after cochlear implantation. [2022] Treatment with cochlear implants (CIs) in single-sided deaf individuals started less than a decade ago. CIs can successfully reduce incapacitating tinnitus on the deaf ear and allow, so some extent, the restoration of binaural hearing. Until now, systematic evaluations of subjective CI benefit in post-lingually single-sided deaf individuals and analyses of speech intelligibility outcome for the CI in isolation have been lacking. For the prospective part of this study, the Bern Benefit in Single-Sided Deafness Questionnaire (BBSS) was administered to 48 single-sided deaf CI users to evaluate the subjectively perceived CI benefit across different listening situations. In the retrospective part, speech intelligibility outcome with the CI up to 12 month post-activation was compared between 100 single-sided deaf CI users and 125 bilaterally implanted CI users (2nd implant). The positive median ratings in the BBSS differed significantly from zero for all items suggesting that most individuals with single-sided deafness rate their CI as beneficial across listening situations. The speech perception scores in quiet and noise improved significantly over time in both groups of CI users. Speech intelligibility with the CI in isolation was significantly better in bilaterally implanted CI users (2nd implant) compared to the scores obtained from single-sided deaf CI users. Our results indicate that CI users with single-sided deafness can reach open set speech understanding with their CI in isolation, encouraging the extension of the CI indication to individuals with normal hearing on the contralateral ear. Compared to the performance reached with bilateral CI users' second implant, speech reception threshold are lower, indicating an aural preference and dominance of the normal hearing ear. The results from the BBSS propose good satisfaction with the CI across several listening situations.

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

Effect of unilateral cochlear implant use on contralateral electrically evoked auditory brainstem responses to round window membrane electrical stimulation. [2022] Long-term use of a unilateral cochlear implant (CI) may lead to abnormal development of contralateral auditory pathway.

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

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. [2023] Evaluate rates of Advanced Bionics Ultra 3D/Ultra cochlear implant failure in the setting of a worldwide device recall and report surgical and auditory outcomes after revision.

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

Cochlear implantation for single-sided deafness: A multicenter study. [2018] To report the preliminary outcomes of patients with single-sided deafness and asymmetric hearing loss undergoing cochlear implantation at two centers.

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

Investigating long-term effects of cochlear implantation in single-sided deafness: a best practice model for longitudinal assessment of spatial hearing abilities and tinnitus handicap. [2021] To evaluate methods for measuring long-term benefits of cochlear implantation in a patient with single-sided deafness (SSD) with respect to spatial hearing and to document improved quality of life because of reduced tinnitus.

10. France pubmed.ncbi.nlm.nih.gov

Benefit of contralateral hearing aid in adult cochlear implant bearers. [2017] The present study assessed the interest of a contralateral hearing aid (HA) in adult cochlear implant (CI) bearers.

11. China pubmed.ncbi.nlm.nih.gov

[Research progress on cochlear implantation in patients with unilateral deafness]. [2018] Cochlear implantation (CI) is a relatively new therapeutic method for patients with severe-to-profound unilateral sensorineural hearing loss. Acoustic signal can stimulate the ear directly, thus patients can gain better binaural hearing. This passage has reviewed the recent researches about CI for patients suffered from single side deafness. It can improve the ability of sound localization and speech recognition in noisy environment for patients, in addition, it may relieve tinnitus to some degree. But the long-term effect and indication selection still need further study.

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

American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Adult Cochlear Implantation for Single-Sided Deafness. [2023] The indications for cochlear implantation have expanded to include individuals with profound sensorineural hearing loss in the impaired ear and normal hearing (NH) in the contralateral ear, known as single-sided deafness (SSD). There are additional considerations for the clinical assessment and management of adult cochlear implant candidates and recipients with SSD as compared to conventional cochlear implant candidates with bilateral moderate to profound sensorineural hearing loss. The present report reviews the current evidence relevant to the assessment and management of adults with SSD. A systematic review was also conducted on published studies that investigated outcomes of cochlear implant use on measures of speech recognition in quiet and noise, sound source localization, tinnitus perception, and quality of life for this patient population. Expert consensus and systematic review of the current literature were combined to provide guidance for the clinical assessment and management of adults with SSD.

13. Switzerland pubmed.ncbi.nlm.nih.gov

[Treatment of single-sided deafness by cochlear implantation]. [2021] Single sided deafness diminishes speech understanding in noise and sound localization and thereby globally auditory performance. Most patients also suffer from tinnitus and indicate reduced quality of life. Patients have the choice to adapt to the new situation without treatment, to restore pseudostereophonic hearing by contralateral routing of signal (CROS) hearing aids or to restore binaural hearing using a cochlear implant in the deaf ear. This article summarizes the physiological base of binaural hearing and treatment options for single sided deafness with a special emphasis on the cochlear implant.