Venting Effects on Speech Performance

NCT06712693 | Completed FDA Device

• 1 other identifier: SRF-26765
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• AZ Bio Sentences

  Sentences will be presented at a pre-determined Signal-to-Noise Ratio (SNR). The SNR will be the same for all three conditions (Power dome, Vented dome, Open dome). Percent correct will be calculated for all conditions. A higher percentage indicates better performance.

  1 day

Study Arms (1)

Experimental

EXPERIMENTAL

All participants will be tested using all three types of domes: Power, Vented, Open.

Device: Phonak Audeo Infinio Hearing Aid

Interventions

Phonak Audeo Infinio Hearing Aid DEVICE

Receiver-In-Canal hearing aid type that is coupled with either a custom earmold or a dome.

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Experienced hearing aid users
• N3-N4 hearing loss
• Fluent in English; ability to read and write in English
• Able to complete complex tasks
• Willing and able to provide informed consent
• Available for the data collection period

You may not qualify if:

• Self-reported active ear-related pathology (otorrhea, dizziness, sudden hearing loss or worsening of hearing, otalgia)
• Visible deformity of the ear
• Chronic, severe tinnitus
• Unilateral hearing loss
• Cognitive impairment

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will know they are being fit with hearing aid, but will not be told which vent size or dome they are being fit with for any of the tests. The investigator scoring the speech test will not know which vent size/dome participant is wearing.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each participant will be fit with the investigational devices under three conditions: Power dome, Vented dome, and Open dome. Participant will complete the same tests under each condition. All participants will complete the same conditions.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: November 11, 2024
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: May 4, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)