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OpenTrials
Completed

NCT Number: NCT03699735

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

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

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bolero B90-SP

Device

Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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