Auditory Training for Cochlear Implant Recipients

Overseen By Nicole M. Tombers, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Revision implantation, Unilateral deafness, others

Compensation: Varies

Number of Visits: 3

Duration: 12 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a computer program called Sound Success to determine if it helps people with cochlear implants understand speech better and improve their quality of life compared to usual self-directed training. It targets adults who recently received cochlear implants at the Mayo Clinic and have significant hearing loss in both ears. Participants must be comfortable using a computer and speak one of the languages supported by the program, such as English or Spanish. As an unphased trial, it provides a unique opportunity to explore innovative solutions for enhancing communication and quality of life.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this auditory training program is safe for cochlear implant recipients?

Research has shown that Sound Success, a computer-based listening program, was created for people with cochlear implants. Although specific safety data for Sound Success is unavailable, using a software application generally involves very low safety risks.

Other studies have examined cochlear implants from Advanced Bionics, the company that developed Sound Success, for safety and effectiveness. These studies indicate that the implants are usually well-tolerated. For instance, a study on remote cochlear implant programming found no major safety issues, suggesting that the company's technology is considered safe for users.

The study's "Not Applicable" phase label indicates that Sound Success is not a new drug or surgical treatment but a supportive tool, likely posing low risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the auditory training called Sound Success because it offers a novel approach to improving hearing outcomes for cochlear implant recipients. Unlike the standard of care, which might involve general hearing therapy or device adjustments, Sound Success focuses on personalized auditory exercises designed to enhance the brain’s ability to process sound. This method could lead to more effective adaptation to cochlear implants, potentially offering faster and more significant improvements in speech understanding and overall hearing experience.

What evidence suggests that this trial's treatments could be effective for improving speech recognition and quality-of-life in cochlear implant recipients?

Research has shown that computer programs like Sound Success, which participants in this trial may receive, can help new cochlear implant users understand speech better and improve their quality of life. Studies have found that independent training can lead to better results in just three months. This program helps users practice and improve their listening skills in an organized way. Evidence supports that this kind of training can boost real-world communication skills, making it a valuable tool for those adjusting to a cochlear implant. ^{1 2 6 7 8}

Who Is on the Research Team?

Matthew Carlson, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults who have recently received a cochlear implant and are in their first year post-activation. They should be looking to improve speech recognition and quality of life with their new implant.

Inclusion Criteria

I have severe hearing loss in both ears and am getting a cochlear implant at Mayo Clinic.

Exclusion Criteria

I am not getting a cochlear implant for the first time or for both ears at once.

Patients unable or unwilling to use a computer or similar device will be excluded from enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo computer-based auditory training using the Sound Success program or standard patient-directed auditory training

12 months

Regular visits as per study protocol

Follow-up

Participants are monitored for changes in cochlear implant quality of life and speech recognition

12 months

Assessments at baseline, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Sound Success
• Standard of Care

Trial Overview

The study compares Sound Success, a free computer-based auditory training program, with the standard patient-directed auditory training to see which one better improves speech recognition and quality-of-life for new adult cochlear implant users.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Group II: Control Group Placebo Group 1 Intervention

Sound Success is already approved in United States, European Union for the following indications:

Approved in United States as Sound Success for:

• Improving speech recognition and quality-of-life in adult cochlear implant recipients

Approved in European Union as Sound Success for:

• Supporting auditory rehabilitation and speech development in cochlear implant users

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A study involving 29 adult cochlear implant users with partial deafness found that while the proposed auditory training was deemed useful for rehabilitation, it was also considered difficult, particularly for identifying mid- and high-frequency sounds.

Women reported significantly more difficulties than men in performing the auditory training exercises, highlighting the need for tailored support in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of the auditory training of the subjects presenting with partial deafness following cochlear implantation as reported by the patients and speech therapists]. Solnitsa, I., Kobosko, I., Pankovska, A., et al.[2014]

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]

A survey of 78 Australian audiologists revealed that 85.5% consider auditory training (AT) essential for adult cochlear implant users, with home-based and face-to-face methods being the most common delivery approaches.

Cost analysis showed that home-based AT is the most economical option for both clients and service providers, while face-to-face training incurs the highest costs, highlighting the importance of delivery method in rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Training for Adult Cochlear Implant Users: A Survey and Cost Analysis Study. Reis, M., Boisvert, I., Beedell, E., et al.[2020]

New minimum standards for reporting outcomes of adult cochlear implants have been established to improve consistency and comparability across clinical trials, endorsed by key committees in otolaryngology.

These standards aim to address the current variability in data reporting, which has hindered effective meta-analyses and the ability to draw significant conclusions from larger patient cohorts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimum Reporting Standards for Adult Cochlear Implantation. Adunka, OF., Gantz, BJ., Dunn, C., et al.[2021]

Cochlear implant patients often require additional auditory rehabilitation beyond the implantation itself to fully benefit from the device, as learning to interpret electrically stimulated speech can be challenging.

A new computer-assisted speech-training program has been shown to effectively improve speech recognition in cochlear implant patients by providing targeted training, auditory and visual feedback, and maintaining patient engagement, making rehabilitation more accessible and motivating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Assisted Speech Training for Cochlear Implant Patients: Feasibility, Outcomes, and Future Directions. Fu, QJ., Galvin, JJ.[2021]

Profoundly deaf children with cochlear implants can achieve significant improvements in hearing and speech abilities, especially when they receive consistent auditory training.

The House Ear Institute is creating extended training protocols that focus on integrating hearing into various environments, using a three-component framework to enhance listening skills and speech development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptual capabilities with the cochlear implant: implications for aural rehabilitation. Eisenberg, LS.[2019]

Group interventions for adult cochlear implant users, such as Auditory Training Groups and Thematic Group Workshops, are well accepted and rated positively by participants, indicating their effectiveness in rehabilitation.

Participants highlighted the importance of training in speech perception in noise and communicative exchange, suggesting that these group settings can enhance both auditory skills and social interaction among CI users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Auditory group therapy in adult cochlear implant rehabilitation]. Glaubitz, C., Lehmann, EK., Weber, L., et al.[2020]

Cochlear implantation significantly improves speech recognition and patient-reported outcomes in adults with severe-to-profound hearing loss, with average Dantale I scores increasing from 26% to 70% in quiet conditions and from 12% to 42% in noisy conditions after implantation.

The study, involving 39 Danish adult patients assessed before and at two points after implantation, shows that while significant improvements were noted at 4 months, further marginal gains were observed at 14 months, suggesting patients approach a performance plateau over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear Implantation Improves Both Speech Perception and Patient-Reported Outcomes: A Prospective Follow-Up Study of Treatment Benefits among Adult Cochlear Implant Recipients. Rasmussen, KMB., West, NC., Bille, M., et al.[2022]

Children with cochlear implants (CIs) who were implanted early showed better social skills and academic competence compared to their late-implanted peers, indicating the importance of early intervention for better developmental outcomes.

There was a significant correlation between language skills and social skills in children with CIs, suggesting that improving language abilities can positively impact their social interactions and academic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of Language, Behavioral, Academic, and Social Skills of Cochlear Implant Users in Early Primary Education. İkiz, M., Yücel, E.[2022]

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]

A study involving 15 adult cochlear implant (CI) users showed that a computer-based auditory training program significantly improved their ability to discriminate between phonemes, particularly consonants, over a 3-week period.

The training specifically enhanced discrimination skills for both voiced and unvoiced consonants, indicating that such programs can be effective tools for auditory rehabilitation in CI listeners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phoneme discrimination training with experienced cochlear implant listeners]. Schumann, A., Liebscher, T., Hoppe, U.[2018]

Out of 308 implanted Ultra (V1) and Ultra 3D (V1) cochlear devices, 21.1% experienced failures, primarily linked to a recent voluntary field corrective action, with an average failure time of 2.2 years.

Most patients (82.5%) opted for revision surgery, and by 3 months post-surgery, many regained or improved their speech recognition scores, indicating effective recovery after device replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HiRes Ultra Series Recall: Failure Rates and Revision Speech Recognition Outcomes. Lindquist, NR., Cass, ND., Patro, A., et al.[2023]

Citations

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Auditory Training for Cochlear Implant Recipients

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The purpose of this study is to compare the effectiveness of a free computer-based auditory training program, Sound Success (Advanced Bionics, Valencia, CA),

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Given its availability and low cost, this study provides evidence to support using CBAT to improve real-world functional abilities in new adult CI recipients.

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