Benefit of a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) Program in Adults

NCT07719114 | Not Yet Recruiting

• 1 other identifier: STUDY20260791
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 care. The main questions are:

1. 1.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?
2. 2.How do new adult users of entry-level hearing aids perceive audiological care practices with and without the CSSAR intervention?

Conditions

Hearing Loss

Keywords

hearing aids; aural rehabilitation; adults; hard of hearing

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 3 Months Post Phase I CSSAR Intervention, 3 Months Post Phase II CSSAR Intervention

Study Arms (2)

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

Behavioral: Clinically Streamlined and Structured Aural Rehabilitation (CSSAR)

Interventions

Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kristina Bowdrie, AuD, PhD

CONTACT

216-368-0957; kab177@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)