Speech Understanding and Listening Effort Benefits of Hearing Instruments
ConditionHearing Loss, Bilateral
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorSonova AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult 18-95 years
N3 or N4 hearing loss
Experienced hearing aid user
English fluency
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
hearing instruments
DeviceParticipants will be fit with three different models of hearing instruments.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Hearing instrument usersExperimental treatment 1 intervention
Trial outcomes
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.
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 outcomes
1
Listening Effort as assessed by the Adaptive Categorical Listening Effort Scaling (ACALES)
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
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.Other outcomes
1
Hearing Instrument Device Preference Questionnaire
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sonova AG
Lead sponsor
University of South Florida
Collaborator
Source ClinicalTrials.gov