Evaluation of a New Noise Reduction Strategy in Hearing Aids

NCT06138665 | Completed Results FDA Device

• 1 other identifier: SRF-20473
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this exploratory interventional study is to evaluate a new hearing aid noise-reduction strategy in experienced hearing aid users, compared to currently available strategies. The primary objective is to measure speech in noise performance with a new strategy and compare to the performance with currently available strategies via a coordinate response measure task.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Coordinate Response Measure

  Test measures speech perception in the presence of 5 competing talkers, presented from 5 speakers located in front of the participant. The talkers are presented sequentially with a brief offset of 1.2 seconds. One of the talkers is the target talker and the participant is instructed to listen for a specific call sign, which identifies the target talker. The participant is prompted to identify the color and number that is subsequently spoken by the target talker. The location of the target talker is randomized from the five locations in the front hemisphere. A score of correctly repeated color and number is calculated and a higher score is better. The dB levels at which the target talker and competing talkers are presented are determined individually for each participant by the Speech in Noise Test, described in Outcome 4.

  1 day (lab visit 2)

Secondary Outcomes (2)

• ACALES (Adaptive Categorical Listening Effort Scaling)

  1 day (lab visit1)

• Subjective Rankings of Each Hearing Aid

  1 day (lab visit 1)

Study Arms (6)

Device A, then Device B, then Device C

EXPERIMENTAL

Participants fit with investigational device (device A), then comparator device B, then comparator device C

Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C

Device B, then Device A, then Device C

EXPERIMENTAL

Participants fit with comparator device B first, then investigational device (device A), then comparator device C

Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C

Device A, then C, then B

EXPERIMENTAL

Participants fit with investigational device A first, then comparator device C, then comparator device B

Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C

Device B, then Device C, then Device A

EXPERIMENTAL

Participants fit with comparator device B first, then comparator device C, then investigational device A

Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C

Device C, then B, then A

EXPERIMENTAL

Participants fit with comparator device C first, then comparator device B, then investigational device A

Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C

Device C, then A, then B

EXPERIMENTAL

Participants fit with comparator device C first, than investigational device A, then comparator device B

Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C

Interventions

Phonak Audeo Infinio Sphere DEVICE

Experimental device

Device A, then C, then B; Device A, then Device B, then Device C; Device B, then Device A, then Device C; Device B, then Device C, then Device A; Device C, then A, then B; Device C, then B, then A

Hearing aid B DEVICE

Active comparator device from different manufacturer that is currently available

Device A, then C, then B; Device A, then Device B, then Device C; Device B, then Device A, then Device C; Device B, then Device C, then Device A; Device C, then A, then B; Device C, then B, then A

Hearing aid C DEVICE

Active comparator device from different manufacturer that is currently available

Device A, then C, then B; Device A, then Device B, then Device C; Device B, then Device A, then Device C; Device B, then Device C, then Device A; Device C, then A, then B; Device C, then B, then A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral and symmetrical severe hearing loss
• experienced hearing aid user 6 months+ hearing aid use
• good understanding of English language
• able and willing to wear RIC style hearing aids with custom earpieces

You may not qualify if:

• unilateral hearing loss
• mild hearing loss
• inability to follow verbal directions
• presence of ear infection, middle ear fluid, dizziness, or worsening of hearing loss within last 90 days

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Phonak Audiology Research Center

Aurora, Illinois, 60504, 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: Principal Investigator
• Organization: Sonova USCS

phonakaudiologyresearch@gmail.com

630.821.5000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded as to which device they are wearing for testing.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will undergo multiple speech in noise tasks and a listening effort task with a Phonak hearing aid and two comparator hearing aids.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: November 20, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 19, 2026
• Results First Posted: August 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)