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

Mayo Clinic logo

Mayo Clinic

Status

Enrolling

Conditions

Bilateral Sensorineural Hearing Loss
Cochlear Implants

Treatments

Behavioral: Sound Success
Behavioral: Standard of Care

Study type

Interventional

Funder types

Other

Identifiers

NCT06607146
22-010096

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups, including a placebo group

Control Group
Placebo Comparator group
Treatment:
Behavioral: Standard of Care
Experimental Group
Experimental group
Treatment:
Behavioral: Sound Success

Trial contacts and locations

1

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Central trial contact

Nicole M. Tombers, RN

Data sourced from clinicaltrials.gov

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