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Speech Understanding and Listening Effort Benefits of Hearing Instruments

Speech Understanding and Listening Effort Benefits of Infinio Sphere

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07116135
Enrollment
30
Registered
2025-08-11
Start date
2025-02-05
Completion date
2025-12-31
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Bilateral

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.

Interventions

DEVICEhearing instruments

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

Sponsors

University of South Florida
CollaboratorOTHER
Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Speech intelligibility as assessed by the Coordinate Response Measure (CRM) TaskData 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.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.

Secondary

MeasureTime frameDescription
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.The ACALES is an adaptive measure of listening effort where the target and interfering background signals are adapted according to participant feedback. Following the target presentation, participants rate listening effort on a 14-point scale

Other

MeasureTime frameDescription
Hearing Instrument Device Preference QuestionnaireData 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.Participants are asked to subjectively rate elements of sound quality and overall preference of the devices under test following standardized presentation of speech-in-noise stimuli in the lab environment.

Countries

United States

Contacts

Primary ContactStudy Coordinator
ant-lab@usf.edu813-974-4148

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026