Venting Effects on Speech Performance | NCT06712693

Studies
Venting Effects on Speech Performance

NCT06712693

Sponsor

Sonova AG

Status

Completed

Last Update Posted

May 4, 2025Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Hearing Loss

Interventions

Phonak Audeo Infinio Hearing Aid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2024Actual

Primary Completion Date

Jan 23, 2025Actual

Completion Date

Jan 23, 2025Actual

First Submitted Date

Nov 26, 2024

First Submission Date that Met QC Criteria

Nov 26, 2024

First Posted Date

Dec 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2025

Last Update Posted Date

May 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	All participants will be tested using all three types of domes: Power, Vented, Open.	Device: Phonak Audeo Infinio Hearing Aid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phonak Audeo Infinio Hearing Aid	Device	Receiver-In-Canal hearing aid type that is coupled with either a custom earmold or a dome.	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:

18-85 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

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phonak Audiology Research Center		Aurora	Illinois	60504	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.

Masking Info

Masking

None (Open Label)

Masking Description

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.

Who Masked

Not provided