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

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ClinicalTrials.gov Identifier: NCT01877317
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Two Pi Signalprocessing Applications GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild to Moderate Sensorineural Hearing Loss Device: SelfFit adjusted hearing device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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



Other Outcome Measures:
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877317


Locations
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Netherlands
Department of Clinical & Experimental Audiology of the Academic Medical Centre
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Two Pi Signalprocessing Applications GmbH
Investigators
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Principal Investigator: Wouter A Dreschler, Prof.dr.ir. Department of Clinical & Experimental Audiology of the Academic Medical Centre in Amsterdam

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Responsible Party: Two Pi Signalprocessing Applications GmbH
ClinicalTrials.gov Identifier: NCT01877317     History of Changes
Other Study ID Numbers: ZIT-653820
NL44209.018.13 ( Other Identifier: Dutch Medical Ethics Review Committee )
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Two Pi Signalprocessing Applications GmbH:
Audiology
hearing loss
hearing healthcare
mobile app
hearing aid fitting
audiometry
audiogram
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms