Individually-guided Hearing Aid Fitting | NCT03345654

Studies
Individually-guided Hearing Aid Fitting

NCT03345654

Sponsor

Northwestern University

Status

Completed

Last Update Posted

May 2, 2025Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Hearing Loss

Interventions

Hearing Aids

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

Apr 2025

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

Sep 8, 2023Actual

Primary Completion Date

Nov 8, 2024Actual

Completion Date

Nov 8, 2024Actual

First Submitted Date

Nov 14, 2017

First Submission Date that Met QC Criteria

Nov 14, 2017

First Posted Date

Nov 17, 2017Actual

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

Apr 29, 2025

Last Update Posted Date

May 2, 2025Actual

Name	Class
University of Colorado, Boulder	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This translational project aims to optimize the fitting of hearing aids by development and clinical validation of a toolset that guides signal processing choice based on the individual auditory and cognitive abilities of the patient.

Detailed Description

The clinical trial portion of the project will validate clinical use of the toolset by evaluating a population of patients fit using current standard of care. Patient characteristics, such as audiological profile and cognition, will be collected. Their hearing aid settings will then be evaluated to determine if they meet toolset guidelines for signal processing based on their patient characteristics (auditory and cognition). Data regarding subjective and objective hearing aid outcomes will also be collected. It is hypothesized that hearing aid fittings that meet the standards of the proposed clinical toolset will result in better patient outcomes (objective and subjective) and fewer post-fitting visits.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
New Hearing Aid Users fit with standard-of-care		Adults (18+) with hearing loss and newly fit with hearing aids	Other: Hearing Aids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hearing Aids	Other	The signal processing of newly fit hearing aids will be evaluated for acceptability based on the toolset, which takes additional patient information beyond hearing threshold (like cognition) to determine the optimal hearing aid signal processing strategies.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Speech intelligibility	Repeat low-context sentences	Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later

Secondary Outcomes

Measure	Description	Time Frame
Post-fitting adjustment visits	Number of times hearing aid adjustments are made post-fitting	First 30 days of fitting
Speech and Spatial qualities questionnaire (SSQ)	Questionnaire evaluating subjective perception of hearing ability in different environments

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sensorineural hearing loss with pure-tone thresholds 70 dB HL or better at octave frequencies between 250 and 4000 Hz, 4 (.5, 1, 2, 3 kHz)
frequency pure-tone average (PTA) of ≥ 30 dB HL.
Listeners will have symmetrical losses, defined here as a 4-frequency PTA difference between ears ≤ 20 dB HL.

Exclusion Criteria:

recent (within last 12 months) hearing aid use
conductive loss (air-bone gaps > 10 dB at any frequency and/or abnormal immittance) -
scoring < 23 on the Montreal Cognitive Assessment
Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
Significant history of otologic or neurologic disorders
Non English speaking participants
Any clinically significant unstable or progressive medical condition
Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Population will be recruited from the Northwestern University Center for Audiology, Speech, Learning, and Language. They will be adults (18+) who are new hearing aid users with no recent prior hearing aid experience. Any patient at the clinic who purchases a new pair of hearing aids and meets the study criteria will be provided information about the study.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Evanston	Illinois	60208	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

ID	Term
D000076251	Wearable Electronic Devices
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D012682	Sensory Aids