Noise Reduction Preferences in Teenagers and Pre-teens

NCT05372094 | Completed Results FDA Device

• 1 other identifier: SRF-802
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Subjective Rating of Listening Effort Questionnaire

  Participant will rate perceived listening effort during a speech in noise task with different levels of noise reduction. Participants will rate how easy the task seemed using a sliding scale with 100 increments between two verbal anchors: "it was very easy" to "it was not easy at all". Higher scores indicate higher perceived listening effort. A rating of "0" would indicate "it was very easy" to understand the speech while a rating of "100" would indicate "it was not easy at all" to understand the speech.

  Day 14 of study, visit 2

Secondary Outcomes (5)

• Speech Reception Threshold

  Day 28, visit 3

• Physical Response Time

  Day 14 of study, visit 2

• Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings

  Day 1 of study, visit 1

• Subjective Questionnaire on Preference for Accessing Bluetooth on Phone

  Day 28, visit 3

• Verbal Response Accuracy

  Day 14 of study, visit 2

Study Arms (1)

Experimental

EXPERIMENTAL

Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.

Device: Phonak Hearing Aid

Interventions

Phonak Hearing Aid DEVICE

Commercially available hearing aid with various noise reduction strengths

Experimental

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• mild, moderate, or moderate-severe bilateral sensorineural hearing loss
• native English speakers with ability to communicate verbally
• able to read and follow directions
• access to smartphone and willing to download a hearing aid app
• experienced hearing aid user (6+ months)

You may not qualify if:

• unable to follow verbal directions
• unable to communicate verbally
• unable to wear study devices for required home trials
• active middle ear infection
• unable to attend lab visits required for study

Sponsors & Collaborators

• Sonova AG: lead
• Vanderbilt University: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director of Research
• Organization: Sonova US

phonakaudiologyresearch@gmail.com

630-821-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be blinded as to which noise reduction setting they are listening to during lab visit objective testing only.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will be fit with hearing aids with the same noise reduction feature. This feature has distinct, discrete levels of noise reduction which will be evaluated by the participants.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 12, 2022
• Study Start: February 23, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 9, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)