Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

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).

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Sensorineural Hearing Loss
• Intervention / Treatment: Device: Phonak Bolero M90-M; Device: Roger Select

Detailed Description

In this study one CE-labeled Phonak Behind-the-ear (BTE) devices is investigated including CE-labeled compatible accessories. The experimental device will be investigated regarding its performance of speech understanding in noise with and without an accessory existing of an external microphone to pick sound at a certain target. A secondary objective of this study is the investigation of the Overall system stability in daily life situations. The experimental device contains direct connectivity functionality. Another objective of this study is the investigation of the subjective occlusion effect of different acoustic couplings. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

• Study Type: Interventional
• Enrollment (Actual): 20
• 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
• Informed Consent as documented by signature
• owning a compatible smartphone
• Hearing loss in range of N2-N3 (ISO 60118-15)

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: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phonak Bolero M90-M; The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss	Device: Phonak Bolero M90-M; The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss
Active Comparator: Roger Select; The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.	Device: Roger Select; The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech intelligibility in noise	The primary objective of this study is to investigate the speech intelligibility in noise of the investigational device alone versus the active comparator. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the value of speech intelligibility in percentage at a certain signal to noise ratio.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Sound quality perception	The secondary objective of this study is to investigate the overall sound quality perception of the investigational device for daily real life situations. The sound quality perception will be measured with a subjective satisfaction rating scale ranging from 0% to 100%.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective occlusion effect	Another objective of this study is to investigate the subjectively perceived occlusion effect of the own voice by the use of the investigational device. The subjective occlusion effect will be investigated with subjective ratings scales for the dimensions 'dullness of own voice' and 'naturalness of own voice'	4 weeks
Sound quality for streamed audio signals	Another objective of this study is to evaluate the subjectively perceived sound quality of streamed audio signals [via bluetooth streaming] with the help of a subjective rating scale	1 week

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): July 6, 2019
• Study Completion (Actual): July 6, 2019

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

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: Sonova2019_19

Drug and device information, study documents

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