Hearing Aid Algorithms for Sudden Sounds

NCT06340919 | Enrolling By Invitation FDA Device

• 1 other identifier: 1406014978-241
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the impact of hearing aid settings for managing sudden sounds on speech comprehension and recall in individuals with hearing loss. Participants will undergo a comprehensive audiological evaluation, case history, and cognitive assessments. Subsequently, they will participate in listening experiments designed to measure sentence recognition, storage, and retrieval under various sudden sound reduction conditions recorded through a hearing aid. The experiment will be complemented by subjective preference ratings to identify participant comfort and listening clarity associated with different sudden sound reduction settings.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (3)

• Speech recognition

  Number of keywords repeated from a sentence just heard

  Through study completion, on average 2 hours

• Recall

  Number of keywords repeated from a sentence heard previously

  Through study completion, on average 2 hours

• Preference

  Paired comparison, preference ratings

  Through study completion, on average 2 hours

Study Arms (4)

Control

NO INTERVENTION

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to OFF.

Low Sudden Sound Reduction

EXPERIMENTAL

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to Low.

Device: Sudden Sound Reduction Setting

High Sudden Sound Reduction

EXPERIMENTAL

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to High.

Device: Sudden Sound Reduction Setting

Maxiumum Sudden Sound Reduction

EXPERIMENTAL

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to Maximum.

Device: Sudden Sound Reduction Setting

Interventions

Sudden Sound Reduction Setting DEVICE

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to Low, High, or Maximum. Recordings with the different settings will be randomized from trial to trial.

High Sudden Sound Reduction; Low Sudden Sound Reduction; Maxiumum Sudden Sound Reduction

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Air conduction thresholds 25-70 dB HL from 2000 - 6000 Hz
• Native English speakers

You may not qualify if:

• Retrocochlear hearing loss

Sponsors & Collaborators

• Purdue University: lead
• Oticon: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, 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

Study Officials

• Joshua Alexander, Ph.D.

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 2, 2024
• Study Start: February 21, 2024
• Primary Completion: September 30, 2024
• Study Completion: May 31, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon formal acceptance of the published manuscript; to be stored indefinitely.
• Access Criteria: Open

Locations

US (1)