Quality Control of CE-Certified Phonak Hearing Aids - 2018_28

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 investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Sensorineural Hearing Loss
• Intervention / Treatment: Device: Successor of Phonak Audéo B90; Device: Phonak Audéo B90

Detailed Description

In this study a comparison with two CE-labeled Phonak Receiver-in-the-canal (RIC) devices is done. The experimental device and the active comparator will be compared regarding Sound Quality perception and speech intelligibility in Quiet and in Noise. The experimental device contains direct connectivity functionality which will be investigated in terms of streamed Audio quality, streaming stability and Usability preferences of functions and Features which are related to direct connectivity. The active comparator device does not contain direct streaming functionality. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich
    • Stäfa, Zürich, Switzerland, 8712
      • Sonova AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 a compatible smartphone

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Successor of Phonak Audéo B90; The successor of the Phonak Audéo B90 is a Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss.	Device: Successor of Phonak Audéo B90; Successor of the most recent Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.
Active Comparator: Phonak Audéo B90; The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.	Device: Phonak Audéo B90; The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of subjective acceptance of the default Hearing aid setting	The Primary Outcome measure of this study is the comparison of the default Hearing aid Fitting (first fit) in regard of the subjective acceptance rating between the experimental device and the active comparator (non-inferiority test design). The first fit acceptance will be measured via subjective satisfaction rating of different dimensions concerning sound quality perception and loudness perception (Scale of satisfaction rating ranging from 0% to 100%).	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Sound Quality rating of streamed telephone call (experimental device only)	The secondary Outcome measure of this study is the Evaluation of the perceived Sound Quality (rated via subjective satisfaction rating) of the streamed telephone signal, which will be streamed between a smartphone and the experimental device.	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Speech intelligibility in noise	Another Outcome measure of this study is the Evaluation of speech understanding in noise of the experimental device and the active comparator. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the Signal-to-noise ration (SNR) in dB.	10 weeks
Evaluation of Speech intelligibility in quiet	Another Outcome measure of this study is the Evaluation of speech understanding in quiet of the experimental device and the active comparator. Speech understanding in quiet will be evaluated with an objective and validated test procedure, the Outcome measure will be the speech intelligibility in % at certain Levels of loudness.	10 weeks
Evaluation of the Bluetooth stability (experimental device only)	Another outcome measure of this study is the investigation of bluetooth stability of the experimental device in terms of connection losses and interruptions. The bluetooth stability will be measured via interview and questionnaires during and after a home trial for the experimental device only. The active comparator device does not have Bluetooth Technology.	10 weeks
Evaluation of Usability preferences (experimental device only)	Another Outcome measure is the qualitative rating of user preferences when using direct connectivity Technology in Terms of streaming an audio signal from an external device with Bluetooth Technology to the experimental device. The user preferences will investigated via rating scales client on a questionnaire during a home trial period	10 weeks

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): November 23, 2018
• Study Completion (Actual): December 23, 2018

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: Sonova2018_28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No