NCT02555462

Brief Summary

Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

September 14, 2015

Last Update Submit

April 3, 2017

Conditions

Validation Studies

Outcome Measures

Primary Outcomes (2)

  • Distance (mm) from probe tube to eardrum measurement

    Precise of the Probe Tube placement

    1 month

  • Procedure time (min) of fitting workflow including Real Ear measurement

    In addition to the outcome measurement "time" (in minutes) further outcome measurements can be obtained due to the performed real ear measurement procedure itself. Data that give information pertaining to test reliability (in dB) and precision of hearing aid fitting (in dB).

    2 month

Secondary Outcomes (2)

  • Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)

    1 month

  • Questionnaire about perceived annoyance

    2 month

Study Arms (1)

Real-Ear Measurement

EXPERIMENTAL

The study arm goes through a comparative test run followed by a comparative hearing aid fitting.

Device: Real-Ear Measurement system integrated in hearing aid fitting software

Interventions

Real-Ear Measurement system integrated in hearing aid fitting softwareDEVICE

The subjects individual response of the ear canal gets measured with the help of a probe tube and a following hearing aid fitting.

Real-Ear Measurement

Eligibility Criteria

Age16 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clean and healthy ear canal, eardrum and pinna
  • Ability to keep current position (of head and body) during a period of about 5 minutes while seated.

You may not qualify if:

  • Ear infections
  • Ear wax in the ear
  • Hyperacusis
  • Pacemaker
  • Tremor
  • Disability to keep position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phonak AG

Stäfa, Canton of Zurich, 8712, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 21, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations

CH(1)