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NCT Number: NCT06607146

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

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.

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Key information

Conditions

Cochlear Implants Bilateral Sensorineural Hearing Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Jim R Dornhoffer, MD

SUB_INVESTIGATOR

Matthew L Carlson, MD

CONTACT

[email protected]

507-266-1965

Matthew L Carlson, MD

PRINCIPAL_INVESTIGATOR

Nicole M. Tombers, RN

CONTACT

[email protected]

507-293-2445

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sound Success

Behavioral

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

Behavioral

Subjects will be provided a list of common exercises for auditory training. This is the current standard of care at our institution.

Primary outcomes

  1. Change in Cochlear Implant Quality of Life-35 Profile

    Time frame: Baseline, 3 months, 6 months, 12 months

    The Cochlear Implant Quality of Life-35 (CIQOL-35) Profile is a patient reported questiornaire that assesses the functional abilities of adult cochlear implant recipients within 6 domains: communication, assessing communication ability in different circumstances; emotional, assessing the impact of hearing on emotional well-being; entertainment, assessing the ability to enjoy television, radio, and music; environmental, assessing the ability to distinguish and localize environmental sounds; listening effort, assessing effort and fatigue associated with receptive communication; and social, assessing the ability to interact and enjoy interaction with groups. Scores are calculated for each domain and ranged from 0 (poorest Quality of Life) to 100 (highest Quality of Life).

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole M. Tombers, RN

CONTACT

[email protected]

507-293-2445

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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