Speech Understanding and Listening Effort Benefits of Hearing Instruments

NCT07116135 | Recruiting FDA Device

• 1 other identifier: SRF-22934 STUDY7873
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to investigate the benefits of hearing instrument use in adults with hearing loss. The main questions it aims to answer are: Does hearing instrument use improve speech understanding and listening effort amount people with hearing loss? Researchers will compare varying models of hearing instruments to see how speech understanding and listening effort are impacted. Participants will be asked to wearing varying hearing instruments and participate in lab-based activities to evaluate their speech understanding, listening effort, and subjective preference.

Conditions

Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (1)

• Speech intelligibility as assessed by the Coordinate Response Measure (CRM) Task

  During the CRM task (Bolia et al., 2000), participants are presented with a phrase detailing the following identifiers: target, color, and digit. They must listen for a target name and respond with the corresponding color and digit. Speech intelligibility performance is assessed based on accuracy, or percent correct across all trials conducted in a given condition.

  Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.

Secondary Outcomes (1)

• Listening Effort as assessed by the Adaptive Categorical Listening Effort Scaling (ACALES)

  Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.

Other Outcomes (1)

• Hearing Instrument Device Preference Questionnaire

  Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.

Study Arms (1)

Hearing instrument users

EXPERIMENTAL

Individuals with hearing impairment will be fit with three different models of hearing instruments. They will all be fit with the same hearing instruments, although they will not be aware which model they are using at the time of testing.

Device: hearing instruments

Interventions

hearing instruments DEVICE

Participants will be fit with three different models of hearing instruments.

Also known as: hearing aids

Hearing instrument users

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18-95 years
• N3 or N4 hearing loss
• Experienced hearing aid user
• English fluency
• Cognitively able to complete complex listening tasks

You may not qualify if:

• Outside of specified age range
• Vulnerable populations
• Hearing within normal limits or otherwise not appropriate for hearing instruments under study
• Inability to read, write, or speak English
• Inability to complete complex listening tasks

Sponsors & Collaborators

• Sonova AG: lead
• University of South Florida: collaborator

Study Sites (1)

University of South Florida Auditory Neurosciences & Technology Lab

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Bilateral

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Central Study Contacts

Study Coordinator

CONTACT

813-974-4148; ant-lab@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participant will not know which condition they are being tested in, but all participants will be given the same intervention and not blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 11, 2025
• Study Start: February 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)