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Completed

NCT Number: NCT02298452

Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids

The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phonak AG

Stäfa, Canton of Zurich, 8712, Switzerland

About this study

This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all kinds of hearing loss (sensorineural, conductive, combined)
  • all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
  • mother tongue (swiss) german

Exclusion criteria

Subjects

  • with a reduced mobility unable to attend weekly study appointments
  • without access to a number of different hearing situations
  • with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
  • which are uncooperative so that it is not possible to record a valid pure tone audiogram
  • with a strongly reduced dexterity
  • with psychological problems
  • central hearing disorders

Treatment and study plan

Hearing aid.

Device

The hearing aid will be fitted to the individual hearing loss of the subject.

Primary outcomes

  1. Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles

    Time frame: 3 years

    For the objective measurements in laboratory situation, both a standard German speech sentence test in noise (SRT in dB) and a standard German monosyllable word test in quiet (speech discrimination in percent) are used to compare the speech intelligibility for both platforms. The results of the Venture platform of both tests should be at least the same or better than with the Quest platform.

Secondary outcomes

  1. Subjective ratings of speech intelligibility during home trials

    Time frame: 3 years

    For the subjective rating of speech intelligibility, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Speech intelligibility in quiet: everything - most - half - little - nothing).

  2. Subjective ratings of sound quality during home trials

    Time frame: 3 years

    For the subjective rating of sound quality, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Sound quality for speech in quiet: good - dull - sharp - thin - echo - scratchy - unclear - noisy).

  3. Subjective ratings of usability during home trials

    Time frame: 3 years

    For the subjective rating of usability, questionnaires are used to compare the current platform Quest with the new platform Venture . The subjective impressions are rated by rating scales (e.g. Rating of the opening and closing of the battery door: very easy - easy - neither - difficult - very difficult).

Sponsors and collaborators

Lead sponsor

Phonak AG, Switzerland

Industry

Registry information

Official study title

Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
May 3, 2016

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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