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A Study Protocol for the Validation of UAud in a Clinical Setting.

NCT05043207 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-11-15

No results posted yet for this study

Summary

The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

Conditions

  • Hearing Loss, Sensorineural
  • Hearing Impairment, Sensorineural

Interventions

DIAGNOSTIC_TEST

uAud

Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure

DIAGNOSTIC_TEST

Traditional audiometry

Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • William Demant Fonden

    collaborator UNKNOWN

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Jesper Hvass Schmidt, PhD · SDU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-01
Completion
2024-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043207 on ClinicalTrials.gov