Last reviewed · How we verify

NCT04618315: P-CHAT

P-CHAT: Comparison of Direct to Consumer Delivery Models for Hearing Devices

Completed NA Results posted Last updated 6 March 2025
What this trial tests

NA trial testing Hearing Aids in Hearing Aids in 584 participants. Completed in 30 June 2024.

Timeline
1 December 2020
Primary endpoint
1 April 2024
30 June 2024

Quick facts

Lead sponsorNorthwestern University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment584
Start date1 December 2020
Primary completion1 April 2024
Estimated completion30 June 2024
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Northwestern University

Who can join

Adults 50 to 79, any sex, with Hearing Aids or Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Profile of Hearing Aid Benefit Primary · 6 weeks

66-item self-assessment, disability-based inventory. Participants answer the questionnaire twice, first prior to use of hearing aids and then after hearing aid use. The questionnaire is scored between 0-99% with higher values representing greater difficulty. Benefit is reported as the difference between the two scores with a higher number signifying greater benefit.

GroupValue95% CI
Audiology-Based Best Practice23.3421.43 – 25.26
Consumer Decides23.2721.54 – 25
Efficient Fitting23.3321.25 – 25.12
Hearing Handicap Inventory for the Elderly Secondary · 6 weeks

A self-administered scale to identify problems related to hearing loss. The questionnaire has 25 items and can be scored between 0 and 100. The score after hearing aid use is subtracted from the baseline score (prior to hearing aid use) to obtain the benefit score. The higher the difference the greater the benefit.

GroupValue95% CI
Audiology-Based Best Practice20.6518.11 – 23.19
Consumer Decides21.8319.42 – 24.23
Efficient Fitting19.1516.59 – 21.73
Duration of Hearing Aid Use Secondary · 6 weeks

Average hours of hearing aid use per day.

GroupValue95% CI
Audiology-Based Best Practice8.427.91 – 8.92
Consumer Decides7.186.64 – 7.72
Efficient Fitting6.836.32 – 7.34

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Audiology-Based Best Practice
Serious: 0/182 (0%)
Deaths: 0/182
Consumer Decides
Serious: 0/172 (0%)
Deaths: 0/172
Efficient Fitting
Serious: 0/178 (0%)
Deaths: 0/178
Other adverse events (4 terms — click to expand)

ReactionSystemAudiology-Based Best Pract…Consumer DecidesEfficient Fitting
Receiver Dome in EarEar and labyrinth disorders
Ear ConditionsEar and labyrinth disorders
TinnitusEar and labyrinth disorders
Reduced HearingEar and labyrinth disorders

Data from ClinicalTrials.gov NCT04618315 adverse events section.

Sponsor's own description

Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Hearing Aids

Trials testing the same drug.

Other recruiting trials for Hearing Aids

Currently open trials in the same condition.

Other Northwestern University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04618315.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing