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

Trial Summary

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 data supports the effectiveness of the treatment Sound Success for cochlear implant recipients?

Research shows that targeted auditory training can significantly improve speech recognition for cochlear implant patients, even in challenging listening conditions. Specialized auditory training programs, like computer-assisted speech training, have been effective in enhancing the benefits of cochlear implants by improving patients' speech recognition performance. ^{1 2 3 4 5}

Is auditory training for cochlear implant recipients safe?

The research articles provided do not contain specific safety data for auditory training in cochlear implant recipients, but they do not report any safety concerns related to the training itself. ^{4 6 7 8 9}

How is the Sound Success treatment for cochlear implant recipients different from other treatments?

Sound Success is unique because it involves targeted auditory training that helps cochlear implant recipients improve their ability to recognize speech and sounds, especially in challenging listening environments. This treatment can be conducted at home using computer-assisted programs, making it more accessible and engaging compared to traditional individual therapy sessions. ^{1 4 10 11 12}

What is the purpose of this trial?

The purpose of this study is to compare the effectiveness of a free computer-based auditory training program, Sound Success (Advanced Bionics, Valencia, CA), with the current standard of care of patient-directed auditory training in improving common measures of speech recognition and cochlear implant (CI) specific quality-of-life in new adult CI recipients in their first year post-activation.

Research Team

Matthew Carlson, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

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

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

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. Switzerland 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. [2022]

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

Auditory Training for Adult Cochlear Implant Users: A Survey and Cost Analysis Study. [2020]

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

HiRes Ultra Series Recall: Failure Rates and Revision Speech Recognition Outcomes. [2023]

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

Minimum Reporting Standards for Adult Cochlear Implantation. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Auditory group therapy in adult cochlear implant rehabilitation]. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

[Phoneme discrimination training with experienced cochlear implant listeners]. [2018]

12. Russia (Federation) 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]. [2014]