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Completed

NCT Number: NCT03780374

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

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

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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 and without experience with) hearing aids
  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature

Exclusion criteria

  • Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid
  • Inability to produce a reliable hearing test result
  • Massively limited dexterity
  • Known psychological problems
  • Known central hearing disorders

Treatment and study plan

Phonak Audéo L2M with Sound Processing Principle 1

Device

Compensation of a hearing loss with Sound Processing Principle 1.

Phonak Audéo L2M with Sound Processing Principle 2

Device

Compensation of a hearing loss with Sound Processing Principle 2.

Phonak Audéo L2M with Sound Processing Principle 3

Device

Compensation of a hearing loss with Sound Processing Principle 3.

Primary outcomes

  1. Speech Intelligibility in Noise

    Time frame: 4 weeks

    The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold).

Secondary outcomes

  1. Sound Quality - Overall

    Time frame: 16 weeks

    The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.

    The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent).

  2. Loudness - Laboratory

    Time frame: 8 weeks

    The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test.

    The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud).

  3. Loudness - Daily Life

    Time frame: 16 weeks

    The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire.

    The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud).

  4. Clarity - Daily Life

    Time frame: 16 weeks

    The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire.

    The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear).

  5. Preferred Sound Processing Principle

    Time frame: 16 weeks

    The preferred sound processing principle will be assessed with the aid of a questionnaire.

    The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred).

  6. Naturalness - Daily Life

    Time frame: 16 weeks

    The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire.

    The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural).

  7. Localization - Daily Life

    Time frame: 16 weeks

    The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.

    The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable).

  8. Reverberation - Daily Life

    Time frame: 16 weeks

    The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.

    The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant).

  9. Satisfaction - Overall in Daily Life

    Time frame: 16 weeks

    The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire.

    The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
May 9, 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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