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Recruiting NCT07116135

Speech Understanding and Listening Effort Benefits of Hearing Instruments

No phase Interventional Hearing Loss, Bilateral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hearing instruments.
Who it may be relevant to
Registry conditions: Hearing Loss, Bilateral. Basic parameters: 18 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Speech Understanding and Listening Effort Benefits of Infinio Sphere

Overview

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

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

Primary outcome measures

  • 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.]
Secondary outcome measures (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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of South Florida Auditory Neurosciences & Technology Lab — Tampa

Identifiers

NCT: NCT07116135 · SRF-22934 STUDY7873

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗