Hearing LossCSSARNCT07719114
Benefit of a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) Program in Adults
A study testing Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) in people with Hearing Loss, run by Case Western Reserve University at 1 site in United States.
Trial summary
The goal of this mixed methods clinical trial is to determine whether a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention improves hearing aid outcomes for new adult users, age 55 years and older, of entry-level hearing aid technology compared with adults who receive standard audiological… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Clinically Streamlined and Structured Aural Rehabilitation (CSSAR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2028
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 and over
- Bilateral, symmetric sensorineural hearing loss
- New users of binaural entry-level Phonak Receiver-in-Canal hearing aids (for experimental control)
- Proficiency in English (in order to understand consent documents, experimental English speech recognition tests, and clinically streamlined and structured aural rehabilitation (CSSAR) trainings)
Who cannot join
- Score < 23 on cognitive screener
- Unilateral or asymmetric sensorineural hearing loss
- Conductive or mixed hearing loss
- Experienced hearing aid users or users of advanced level hearing aids
- Less than proficient English speaker
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
Case Western Reserve University
Cleveland, Ohio, 44106
Kristina Bowdrie, AuD, PhD, 2163680957, kab177@case.edu
kab177@case.edu
About this study
Official title: Evaluating the Benefits of Aural Rehabilitation for Adult Users of Entry-Level Hearing Aids
The goal of this mixed methods clinical trial is to determine whether a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention improves hearing aid outcomes for new adult users, age 55 years and older, of entry-level hearing aid technology compared with adults who receive standard audiological care.
The main questions are:
Read more
- Does the CSSAR intervention result in greater hearing aid benefit, improved aided speech-in-noise performance, and reduced self-perceived hearing handicap among adult users of entry-level hearing aids compared with those who receive standard care, such as a hearing aid evaluation, fitting, and orientation, without a structured aural rehabilitation program?
- How do new adult users of entry-level hearing aids perceive audiological care practices with and without the CSSAR intervention?
Participants will be asked to complete four to five sessions. These sessions may include baseline testing, participation in the CSSAR intervention, two follow-up sessions, and a focus group. For participants in the intervention group, the CSSAR intervention will include a training session with a primary communication partner, followed by use of a mobile auditory training program.
- Conditions
- Hearing Loss
- Being tested
- Clinically Streamlined and Structured Aural Rehabilitation (CSSAR)
- Keywords
- hearing aids, aural rehabilitation, adults, hard of hearing
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinically Streamlined and Structured Aural Rehabilitation (CSSAR)Behavioural
Participants assigned to the intervention group will receive standard of care plus CSSAR. CSSAR is designed to add more active rehabilitative support (beyond hearing aids) that is feasible for clinical implementation in practice settings. CSSAR will include two phases. Phase I CSSAR will consist of a one hour, in-person communication support session delivered prior to the hearing aid fitting. The participant will be coached through scenarios in which both they and their communication partner must actively reflect on facilitative or maladaptive communication and repair strategies and on environmental modification. Phase II CSSAR will occur 3 months after the hearing aid fitting, and will consist of auditory training using a free mobile app. Because structured auditory training is rarely incorporated into routine clinical care, often due to time constraints, this phase is designed to provide an additional rehabilitative element that is accessible and feasible in real-world practice.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention - receives only standard audiological care |
| Intervention Group | Experimental | Receives a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention in addition to the standard audiological care Receives: Behavioral: Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Perceived Hearing Aid Benefit
Change in self-perceived hearing aid benefit will be measured using The Abbreviated Profile of Hearing Aid Benefit (APHAB). The APHAB is a 24-item questionnaire consisting of listening experiences across a range of situations with and without hearing aids. Participants indicate on a 7-item scale the percentage of time in which the statement is true from Always (99% of the time) to Never (1% of the time) when unaided and when aided with their devices. The APHAB is a well-used and -accepted clinical questionnaire of perceived hearing aid benefit. Each item loads onto one of four subscales (Ease of Communication, Background Noise, Reverberation, and Aversiveness). Benefit is calculated by subtracting the aided average from the unaided average. The APHAB Benefit score (excluding the Aversiveness subscale) score will be used for analyses, with higher scores suggesting greater benefit.
Measured: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
Self-Perceived Hearing Handicap
Change in self-perceived hearing handicap will be measured using the Revised Hearing Handicap Inventory (R-HHI). Based on the original Hearing Handicap Inventory for Adults (HHIA) and for the elderly (HHIE), the R-HHI consists of 18 items related to hearing-related aspects of psychosocial health including "Does a hearing problem cause you to feel left out when you are with a group of people." The respondent is asked to rate each item with "Yes", "Sometimes", and "No", which correspond to scores of 4, 2, and 0 respectively. Because the R-HHI contains common items across both HHIA and HHIE, it can be used for adults across all ages. The total score will be used for analyses, with higher scores corresponding to greater perceived hearing handicap.
Measured: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
Word Recognition in Noise
Change in word recognition performance will be measured using the Words in Noise (WIN) Test. The WIN consists of Northwestern University Auditory Test No. 6 (NU-6) monosyllabic words, a standardized set of phonetically balanced words commonly used to assess speech-recognition ability, presented in the presence of 6-talker babble that is fixed at 80 dB SPL. There are 35 target words spoken by a female talker within a single list for the WIN, with the signal-to-noise ratio (SNR) decreasing from +24 dB (easiest) to 0 (most difficult) by 4 dB every 5 words. Following practice, two word lists will be administered and averaged to obtain a total score reflected as percent correct. WIN Lists 1 and 2 will be counterbalanced across participants and alternated across the follow-up visits to minimize systematic list-order and repeated-exposure. This total percent of words scored as correct across the two lists will be used for analyses with a higher percentage suggesting better performance.
Measured: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- 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
- Model description
- One group will receive the Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention in addition to the standard of care (e.g., hearing aid evaluation, fitting, and orientation). The other group will not receive the intervention, but will receive the standard of care (e.g., hearing aid evaluation, fitting, and orientation).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Bowdrie, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719114
- Sponsor's protocol ID
- STUDY20260791
- Acronym
- CSSAR
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with researchers upon reasonable request, subject to participant consent, institutional approval, and an appropriate data-use agreement. Aggregate findings, study materials, and analytic code may be shared whenever feasible.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Benefits of Aural Rehabilitation for Adult Users of Entry-Level Hearing Aids
- ClinicalTrials.gov ID
- NCT07719114
- Acronym / sponsor ID
- CSSAR / STUDY20260791
- Conditions
- Hearing Loss
- Keywords
- hearing aids, aural rehabilitation, adults, hard of hearing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jul 2026 (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 goal of this mixed methods clinical trial is to determine whether a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention improves hearing aid outcomes for new adult users, age 55 years and older, of entry-level hearing aid technology compared with adults who receive standard audiological care.
The main questions are:
- Does the CSSAR intervention result in greater hearing aid benefit, improved aided speech-in-noise performance, and reduced self-perceived hearing handicap among adult users of entry-level hearing aids compared with those who receive standard care, such as a hearing aid evaluation, fitting, and orientation, without a structured aural rehabilitation program?
- How do new adult users of entry-level hearing aids perceive audiological care practices with and without the CSSAR intervention?
Participants will be asked to complete four to five sessions. These sessions may include baseline testing, participation in the CSSAR intervention, two follow-up sessions, and a focus group. For participants in the intervention group, the CSSAR intervention will include a training session with a primary communication partner, followed by use of a mobile auditory training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will receive the Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention in addition to the standard of care (e.g., hearing aid evaluation, fitting, and orientation). The other group will not receive the intervention, but will receive the standard of care (e.g., hearing aid evaluation, fitting, and orientation).
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention - receives only standard audiological care |
| Intervention Group | Experimental | Behavioral: Clinically Streamlined and Structured Aural Rehabilitation (CSSAR)Receives a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention in addition to the standard audiological care |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55 and over
- Bilateral, symmetric sensorineural hearing loss
- New users of binaural entry-level Phonak Receiver-in-Canal hearing aids (for experimental control)
- Proficiency in English (in order to understand consent documents, experimental English speech recognition tests, and clinically streamlined and structured aural rehabilitation (CSSAR) trainings)
Key exclusion criteria (5 listed)
- Score < 23 on cognitive screener
- Unilateral or asymmetric sensorineural hearing loss
- Conductive or mixed hearing loss
- Experienced hearing aid users or users of advanced level hearing aids
- Less than proficient English speaker
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 |
|---|---|---|
| Clinically Streamlined and Structured Aural Rehabilitation (CSSAR)Participants assigned to the intervention group will receive standard of care plus CSSAR. CSSAR is designed to add more active rehabilitative support (beyond hearing aids) that is feasible for clinical implementation in practice settings. CSSAR will include two phases. Phase I CSSAR will consist of a one hour, in-person communication support session delivered prior to the hearing aid fitting. The participant will be coached through scenarios in which both they and their communication partner must actively reflect on facilitative or maladaptive communication and repair strategies and on environmental modification. Phase II CSSAR will occur 3 months after the hearing aid fitting, and will consist of auditory training using a free mobile app. Because structured auditory training is rarely incorporated into routine clinical care, often due to time constraints, this phase is designed to provide an additional rehabilitative element that is accessible and feasible in real-world practice. | Behavioural | Intervention Group |
Primary outcome
Self-Perceived Hearing Aid Benefit
Time frame: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
Change in self-perceived hearing aid benefit will be measured using The Abbreviated Profile of Hearing Aid Benefit (APHAB). The APHAB is a 24-item questionnaire consisting of listening experiences across a range of situations with and without hearing aids. Participants indicate on a 7-item scale the percentage of time in which the statement is true from Always (99% of the time) to Never (1% of the time) when unaided and when aided with their devices. The APHAB is a well-used and -accepted clinical questionnaire of perceived hearing aid benefit. Each item loads onto one of four subscales (Ease of Communication, Background Noise, Reverberation, and Aversiveness). Benefit is calculated by subtracting the aided average from the unaided average. The APHAB Benefit score (excluding the Aversiveness subscale) score will be used for analyses, with higher scores suggesting greater benefit.
Self-Perceived Hearing Handicap
Time frame: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
Change in self-perceived hearing handicap will be measured using the Revised Hearing Handicap Inventory (R-HHI). Based on the original Hearing Handicap Inventory for Adults (HHIA) and for the elderly (HHIE), the R-HHI consists of 18 items related to hearing-related aspects of psychosocial health including "Does a hearing problem cause you to feel left out when you are with a group of people." The respondent is asked to rate each item with "Yes", "Sometimes", and "No", which correspond to scores of 4, 2, and 0 respectively. Because the R-HHI contains common items across both HHIA and HHIE, it can be used for adults across all ages. The total score will be used for analyses, with higher scores corresponding to greater perceived hearing handicap.
Word Recognition in Noise
Time frame: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention
Change in word recognition performance will be measured using the Words in Noise (WIN) Test. The WIN consists of Northwestern University Auditory Test No. 6 (NU-6) monosyllabic words, a standardized set of phonetically balanced words commonly used to assess speech-recognition ability, presented in the presence of 6-talker babble that is fixed at 80 dB SPL. There are 35 target words spoken by a female talker within a single list for the WIN, with the signal-to-noise ratio (SNR) decreasing from +24 dB (easiest) to 0 (most difficult) by 4 dB every 5 words. Following practice, two word lists will be administered and averaged to obtain a total score reflected as percent correct. WIN Lists 1 and 2 will be counterbalanced across participants and alternated across the follow-up visits to minimize systematic list-order and repeated-exposure. This total percent of words scored as correct across the two lists will be used for analyses with a higher percentage suggesting better performance.
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 22 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with researchers upon reasonable request, subject to participant consent, institutional approval, and an appropriate data-use agreement. Aggregate findings, study materials, and analytic code may be shared whenever feasible.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) in people with Hearing Loss, run by Case Western Reserve University 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jul 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. 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 Kristina Bowdrie, AuD, PhD (216-368-0957, kab177@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Perceived Hearing Aid Benefit (time frame: Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention). The study lists 3 primary outcomes in all. 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 22 Jul 2026.