Cochlear ImplantsNCT06607146
Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes
A study testing Sound Success in people with Cochlear Implants and Bilateral Sensorineural Hearing Loss, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implants, Bilateral Sensorineural Hearing Loss
- What is being tested?
- Sound Success
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Nicole M. Tombers, RN, 507-293-2445, Tombers.Nicole@mayo.edu
James R. Dornhoffer, MD, 507-266-1965, dornhoffer.james@mayo.edu
About this study
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.
- Being tested
- Sound Success, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound SuccessBehavioural
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 CareBehavioural
Subjects will be provided a list of common exercises for auditory training. This is the current standard of care at our institution.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Not described Receives: Behavioral: Standard of Care |
| Experimental Group | Experimental | Not described Receives: Behavioral: Sound Success |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cochlear Implant Quality of Life-35 Profile
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).
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start9 May 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James R. Dornhoffer, Mayo Clinic
- Investigators
- James R. Dornhoffer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607146
- Sponsor's protocol ID
- 22-010096
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes
- ClinicalTrials.gov ID
- NCT06607146
- Acronym / sponsor ID
- 22-010096
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Standard of Care |
| Experimental Group | Experimental | Behavioral: Sound Success |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound SuccessSubjects 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. | Behavioural | Experimental Group |
| Standard of CareSubjects will be provided a list of common exercises for auditory training. This is the current standard of care at our institution. | Behavioural | Control Group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implants
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James R. Dornhoffer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound Success in people with Cochlear Implants and Bilateral Sensorineural Hearing Loss, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole M. Tombers, RN (507-293-2445, Tombers.Nicole@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cochlear Implant Quality of Life-35 Profile (time frame: Baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.