Study of SelfFit Mobile Medical App for Hearing Loss Diagnostics and Hearing Device Fitting / Fine Tuning (SelfFit)

October 21, 2016 updated by: Two Pi Signalprocessing Applications GmbH

Study of SelfFit App for Hearing Loss Diagnostics Based on Threshold Measurements Through In-situ Audiometry and Adjustment of Hearing Device Amplification Parameters in Agreement With Prescriptive Formulas as NAL-NL1,DSL-i/o

The purpose of this clinical study is to validate the comparability of prescription formula fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting of hearing aids based on hearing loss screening (mild to moderate hearing losses) using in-situ audiometry, provided and executed through the mobile medical app.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The technology utilized within the mobile medical App is partially described in the US patent application US2011/0002490A1. The app is to be used in combination with a hearing aid to deliver the output and targets accurate individual acoustical amplification for effective compensation of a users hearing loss.

The electronic circuitry incorporating the digital signal processing algorithms - dynamic range compression, noise reduction - is providing the acoustical amplification according to parameters (acoustical gain, compression ratio, time constants) calculated through the App on base of in-situ hearing loss diagnostics (pure tone audiometry, loudness scaling). Within the study, amplification parameters will be transmitted to the prototyped device through a prototyped audio streaming box.

Individual audiogram represents hearing thresholds (softest audible sounds) at different frequencies. At least two test frequencies are used involving one in the lower region of device's bandwidth (such as 750 Hz) and one in the higher region of the device's bandwidth (such as 2 kHz). Hearing thresholds are assessed by presenting pure tones of different known levels (SPL) to the user and the thresholds for each of the test frequencies are determined according to the user response to a verbally formulated question (how many tones did you hear?) and multiple choice answer buttons (0, 1, or 2).

Second hearing loss characteristic obtained by the app. is the personal loudness scaling. By presenting a band-limited noise stimuli and collecting the user response about perceived loudness level Medical Mobile App calculates dynamic range of users hearing at given frequency.

The calculation of optimal amplification parameters is performed by App using a proprietary "fitting formula" derived from scientific data.

Final adjustment of amplification parameters called fine tuning is performed while presenting the user with realistic acoustical environment during operation of the hearing device. Fine tuning relates to slight changes of the parameters initially obtained by the "fitting formula". The acoustical signals are presented using audio streaming through the hearing aid. In particular the presented signals include "speech in quiet" and "speech in background noise". Presented speech signal is composed from two or more sources that are processed with different signal processing parameters. During the presentation of the speech signal App presents the speech source visually as two or more speakers. The user is asked to provide his listening preference by choosing the preferred speaker. The signal processing parameters relating to the preferred sound are used for final adjustment of hearing device.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Department of Clinical & Experimental Audiology of the Academic Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hearing loss at the better ear between 35dB and 50dB (PTA1/2/4)
  • Active lifestyle
  • No language problems
  • No medical contra-indications
  • Age: between 18 and 75 years
  • About 50% experienced users and 50% new users
  • Willing to participate in the trial with one three hour visit to the AMC.

Exclusion Criteria:

  • Conductive hearing loss in the middle ear
  • Severe hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SelfFit adjusted hearing device
Hearing impaired people with mild to moderate sensorineural hearing loss (PTA124<50 dB) in the test ear compare the performance of their hearing aids adjusted through SelfFit mobile medical App (I-Pad) with the performance of their hearing aids adjusted through conventional audiogram-based fitting.
Device: SelfFit adjusted hearing device
Comparison of threshold measurements through in-situ audiometry with full diagnostic audiometry; Comparison of First-Fit based on SelfFit-formula with conventional fitting formula NAL-NL1 (IG-measurements; Speech intelligibility with First fit of SelfFit; Speech intelligibility with Final fit of SelfFit; Comparison of fine tuning through SelfFit (Final fit) with First fit; Comparison of Final fit with Traditional fit (conventional fitted hearing aid of the test person)
Other Names:
  • User-fitted hearing device
  • hearing device fitting software
  • home-fitting tool for hearing devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing threshold
Time Frame: June - July 2013 (up to 2 months)

Applicability of in-situ audiometry:

Comparison of pure tone audiometry outcomes: conventional full diagnositic and SelfFit in-situ audiometry
June - July 2013 (up to 2 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech intelligibility - First Fit
Time Frame: June - July 2013 (up to 2 months)

Quality of First-Fit:

Comparison speech audiometry with CVC words @ 55/65/75 db SPL in conventionally adjusted hearing aid and SelfFit adjusted hearing aid
June - July 2013 (up to 2 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech intelligibility - Final Fit
Time Frame: June - July 2013 (up to 2 months)

Quality of Final-Fit:

Comparison speech audiometry with CVC words @ 55/65/75 db SPL in conventionally adjusted hearing aid and SelfFit adjusted hearing aid
June - July 2013 (up to 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Two Pi Signalprocessing Applications GmbH

Investigators

  • Principal Investigator: Wouter A Dreschler, Prof.dr.ir., Department of Clinical & Experimental Audiology of the Academic Medical Centre in Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimate)

June 13, 2013

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZIT-653820
  • NL44209.018.13 (Other Identifier: Dutch Medical Ethics Review Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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