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OpenTrials
Completed

NCT Number: NCT03555084

Quality Control of CE-Certified Phonak Hearing Aids - 2018_07

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

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Key information

Conditions

Hearing Loss, Sensorineural 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 and older

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
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Ability to fill in a questionnaire (p/eCRF) conscientiously
  • willingness to wear custom made Hearing aids
  • Informed Consent as documented by signature
  • Benefit with TFG tool at least on one ear

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 in Stäfa (Switzerland)
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid
  • Inability to produce a reliable hearing test result
  • Limited dexterity (not able to change a 10size Hearing aid battery)
  • no Benefit of the TFG tool on both ears
  • Known psychological problems
  • Central hearing disorders

Treatment and study plan

Extension of Virto B-Titanium

Device

In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.

Virto B-Titanium

Device

In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.

Primary outcomes

  1. Visibility and Wearing Comfort

    Time frame: 3 weeks

    The primary objective of this study is to evaluate if Virto B-Titanium hearing aids measured with the Titanium FitGuide (TFG) (extension of Virto B-Titanium) are less visible (deeper) than modeling without TFG (Virto B-Titanium) while maintaining wearing comfort on adult participants (new and existing users) with mild to moderately-severe hearing loss (M and P receiver ).

Secondary outcomes

  1. Measurement of acoustic Feedback Thresholds

    Time frame: 3 weeks

    Secondary objective is to compare the acoustic feedback thresholds of the TFG- and without TFG- modeled devices in regard of an adequate sealing effect of the respective devices. Thereby, feedback thresholds, measured with the Phonak Target fitting software, must be comparable to average feedback threshold values of the respective shell forms (IIC / CIC). Acceptable feedback thresholds must guarantee an insertion gain [in dB SPL] of at least 20 dB in a specific frequency range.

Other outcomes

  1. TFG Fitrate

    Time frame: 3 weeks

    Another objective is to investigate whether at least 50% of the screened population will get a deeper fitted device by the use of the TFG tool, proven by modelling software

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2018
Registry last updated
Sep 17, 2018

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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