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Completed

NCT Number: NCT02895477

Quest Sound Recover (SR2) vs. Venture SR2

Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform.

To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.

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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

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Ability to fill in a question conscientious
  • Healthy outer ear (w/o previous surgical procedures)
  • Sensorineural symmetric hearing loss (HL)
  • N4 to N7 (degree of HL)

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
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid
  • Inability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
  • Massively limited dexterity
  • Known Psychological problems
  • Central hearing problems

Treatment and study plan

Hearing Aid

Device

Primary outcomes

  1. Functional gain

    Time frame: after 2 weeks

    Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.

  2. Phoneme Perception Test

    Time frame: after 2

    Change of Detection thresholds after 4 weeks hearing instrument wearing time

  3. Functional gain

    Time frame: after 8 weeks

    Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.

  4. Phoneme Perception Test

    Time frame: after 8 weeks

    Change of detection thresholds after 4 weeks hearing instrument wearing time

Secondary outcomes

  1. sound quality ratings

    Time frame: after 6 and 12 weeks

  2. questionnaires

    Time frame: after 2, 6, 8 and 12 weeks

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 9, 2016
Registry last updated
Jan 30, 2017

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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