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NCT Number: NCT07116135

Speech Understanding and Listening Effort Benefits of Hearing Instruments

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.

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Key information

Conditions

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

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida Auditory Neurosciences & Technology Lab

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

[email protected]

813-974-4148

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hearing instruments

Device

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

Other names: hearing aids

Primary outcomes

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

    Time frame: 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.

    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 outcomes

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

    Time frame: 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 outcomes

  1. Hearing Instrument Device Preference Questionnaire

    Time frame: 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

813-974-4148

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • University of South Florida

Registry information

Official study title

Speech Understanding and Listening Effort Benefits of Infinio Sphere

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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