ClinicalTrials.gg
RecruitingNCT07116135Updated Aug 11, 2025

Speech Understanding and Listening Effort Benefits of Hearing Instruments

An interventional study of hearing instruments in Hearing Loss, Bilateral, sponsored by Sonova AG. Recruiting at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Sonova AG · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Feb 2025, registered Jul 2025).
  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hearing Loss, Bilateral
03

In context

Hearing Loss, Bilateral

55 studies on the registry are indexed under Hearing Loss, Bilateral; 17 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 42 interventional studies indexed under Hearing Loss, Bilateral.

Browse Hearing Loss, Bilateral studies →

Lead sponsor

Sonova AG is the lead sponsor of 89 studies on the registry; 6 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Hearing instrument users

    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

  • Devicehearing instruments

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

    Also known as: hearing aids

06

What researchers measure

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.

07

Study locations

1 of 1 sites recruiting
  • University of South Florida Auditory Neurosciences & Technology Lab
    Tampa, Florida 33612, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Dec 2025, 10 months after the start.

Of 27 interventional studies with no phase under Hearing Loss, Bilateral, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 60. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2025
First posted
Aug 11, 2025
StartActual
Feb 5, 2025
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Aug 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07116135
Lead sponsor
Sonova AG
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Feb 5, 2025
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 11, 2025

Study contacts

Study Coordinator
Contact
ant-lab@usf.edu
813-974-4148

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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