Recruiting

Auditory Training

Sponsor:

Mayo Clinic

Code:

NCT06607146

Conditions

Cochlear Implants

Bilateral Sensorineural Hearing Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sound Success

Standard of Care

Study Details

Brief summary:

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.

Conditions

Cochlear Implants

Bilateral Sensorineural Hearing Loss

Study ID

NCT06607146

Start date

May 9, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control Group

experimental: Experimental Group

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Nicole M. Tombers, RN

507-293-2445Tombers.Nicole@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Nicole M. Tombers, RN

507-293-2445Tombers.Nicole@mayo.edu

James R. Dornhoffer, MD

507-266-1965dornhoffer.james@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-05.