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Recruiting NCT06607146

Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes

No phase Interventional Cochlear Implants Bilateral Sensorineural Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sound Success, Standard of Care.
Who it may be relevant to
Registry conditions: Cochlear Implants, Bilateral Sensorineural Hearing Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Sound Success
    Subjects will be instructed to perform auditory training with the Sound Success computer-based auditory training program. This is a free program that requires a brief account registration. Subjects will be instructed to perform auditory training on a personal device and will be recommended a target usage of at least 30 minutes 5 times per week.
  • Behavioral Standard of Care
    Subjects will be provided a list of common exercises for auditory training. This is the current standard of care at our institution.

Primary outcome measures

  • Change in Cochlear Implant Quality of Life-35 Profile [Time frame: Baseline, 3 months, 6 months, 12 months]

Eligibility criteria

Inclusion criteria

  • Adult patients with a diagnosis of bilateral moderate-to-profound sensorineural hearing loss who are undergoing unilateral or simultaneous bilateral cochlear implantation at the Mayo Clinic in Rochester MN.

Exclusion criteria

  • Patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment
  • Patients unable or unwilling to use a computer or similar device will be excluded from enrollment.
  • Patients will be excluded if they speak a language not supported by the Sound Success platform. Sound Success is available in English, Spanish, French, Italian, Dutch, Polish, and Danish.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06607146 · 22-010096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗