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).

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Sensorineural
• Intervention / Treatment: Device: Phonak Audéo B90-Direct; Device: HearingAid_A; Device: HearingAid_B

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 15
• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phonak Audéo B90-Direct; The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss.	Device: Phonak Audéo B90-Direct; 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.
Active Comparator: HearingAid_A; HearingAid_A is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_A which will be fitted to the participants individual Hearing loss.	Device: HearingAid_A; 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.
Active Comparator: HearingAid_B; HearingAid_B is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_B which will be fitted to the participants individual Hearing loss.	Device: HearingAid_B; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the speech intelligibiltity of phone calls via direct streaming	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the subjective Sound Quality rating of TV-Audiostream via direct connectivity	Another outcome measurement of this study is the comparison of streamed audio signals from TV in terms of sound quality (measured via satisfaction rating).	6 weeks
Comparison of the Usability of remote controls via direct connectivity	Another outcome measurement of this study is the comparison of the usability of a remote control via interview during and after home trial.	6 weeks

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

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; Hearing Loss, Sensorineural
• Other Study ID Numbers: Sonova2018_05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No