Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31

May 3, 2019 updated by: Sonova AG

Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • Switzerland
    • Zürich
      • Stäfa, Zürich, Switzerland, 8712
        • Sonova AG

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 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
  • Sensorineural hearing loss (N4-N6 according to ISO 60118-15)
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Informed Consent as documented by signature
  • Symmetric hearing loss below 1000 Hz

Exclusion Criteria:

  • Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments on study site
  • Inability to produce a reliable hearing test result
  • Known psychological problems
  • Central hearing disorders

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hearing Aid with beam form principle_A
Device: Hearing Aid beam former principle_A (simulation of real ear condition). Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Device: Bolero B90-SP
Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss
EXPERIMENTAL: Hearing Aid with beam form principle_B
Device: Hearing Aid beam former principle_B. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Device: Bolero B90-SP
Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss
EXPERIMENTAL: Hearing Aid with beam form principle_C
Device: Hearing Aid beam former principle_C. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Device: Bolero B90-SP
Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual binaural Hearing abilities
Time Frame: 2 weeks
Primary Outcome measurement is to measure the speech understanding in noise [SNR in dB] for the beam former principles A, B and C
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speechunderstanding for different beam form principles
Time Frame: 2 weeks
Secondary Outcome measurement is to measure individual binaural Hearing abilities with psycho acoustical test principles (Binaural inter aural Level difference [SNR in dB] and Binaural Masking Level Difference [SNR in dB] and speech test [Oldenburger Satztest in noise [SNR in dB]. Thereby, the correlation between psycho acoustical test results and speech test results will be analyzed.
2 weeks

Collaborators and Investigators

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

Sponsor

Sonova AG

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 (ACTUAL)

August 6, 2018

Primary Completion (ACTUAL)

December 20, 2018

Study Completion (ACTUAL)

March 29, 2019

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sonova2018_31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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