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Completed

NCT Number: NCT03751891

Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05

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 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–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

About this study

In this study a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices contain direct connectivity functionality which will be compared in terms of streamed Audio quality, streaming stability and Usability preferences of all available functions and features. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (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, mild to moderate Hearing loss) without hearing aid experience
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Ability to fill in a questionnaire (p/eCRF) conscientiously
  • willingness to wear Receiver in the canal hearing aids
  • Informed Consent as documented by signature
  • owning an iPhone 6 or higher

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
  • Known psychological problems
  • Central hearing disorders

Treatment and study plan

Phonak Audéo B90-Direct

Device

The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.

HearingAid_A

Device

HearingAid_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer_A which will be fitted to the participants individual Hearing loss.

HearingAid_B

Device

HearingAid_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer_B which will be fitted to the participants individual Hearing loss.

Primary outcomes

  1. Comparison of the speech intelligibiltity of phone calls via direct streaming

    Time frame: 6 weeks

    The primary outcome meaurement of this study is the comparison of Phonak's direct connectivity solution against two competitors in terms of subjective speech intelligibility of streamed audio signals via smartphone. The subjective speech intelligibilty will be measured via interview (sound quality rating, satisfaction rating of speech intelligibility) from far-end talker and near-end talker.

Secondary outcomes

  1. Investigation of Bluetooth Connection losses between Hearing Aid and smart phone during a phone call (number of reported interruptions during a phone call which will be streamed via bluetooth from Smartphone to Hearing Aid)

    Time frame: 6 weeks

    The secondary outcome measurement of this study is to investigate the number of (Bluetooth-) Connection losses between Hearing Aid and Smartphone during a phone call stream. The bluetooth connection losses will be investigated by counting the reported interruptions of a streamed phone call between smartphone and Hearing Aid in relation to the amount of conducted phone calls during two weeks of home trial for the investigational device and the comparative devices.

Other outcomes

  1. Comparison of the subjective Sound Quality rating of TV-Audiostream via direct connectivity

    Time frame: 6 weeks

    Another outcome measurement of this study is the comparison of streamed audio signals from TV in terms of sound quality (measured via satisfaction rating).

  2. Comparison of the Usability of remote controls via direct connectivity

    Time frame: 6 weeks

    Another outcome measurement of this study is the comparison of the usability of a remote control via interview during and after home trial.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2018
Registry last updated
Nov 23, 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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