Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak Audéo L2M with Sound Processing Principle 1; Device: Phonak Audéo L2M with Sound Processing Principle 2; Device: Phonak Audéo L2M with Sound Processing Principle 3

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Stäfa, Zurich, 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) with and without experience with) hearing aids
• Healthy outer ear (without previous surgical procedures)
• Ability to fill in a questionnaire conscientiously
• Informed Consent as documented by signature

Exclusion Criteria:

• Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
• Limited mobility and not in the position to attend weekly appointments
• Limited ability to describe listening impressions/experiences and the use of the hearing aid
• Inability to produce a reliable hearing test result
• Massively limited dexterity
• Known psychological problems
• Known 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
Active Comparator: Sound Processing Principle 1; Sound Processing Principle 1 will be applied in the hearing aid.	Device: Phonak Audéo L2M with Sound Processing Principle 1; Compensation of a hearing loss with Sound Processing Principle 1.
Experimental: Sound Processing Principle 2; Sound Processing Principle 2 will be applied in the hearing aid.	Device: Phonak Audéo L2M with Sound Processing Principle 2; Compensation of a hearing loss with Sound Processing Principle 2.
Experimental: Sound Processing Principle 3; Sound Processing Principle 3 will be applied in the hearing aid.	Device: Phonak Audéo L2M with Sound Processing Principle 3; Compensation of a hearing loss with Sound Processing Principle 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Intelligibility in Noise	The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sound Quality - Overall	The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent).	16 weeks
Loudness - Laboratory	The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test. The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud).	8 weeks
Loudness - Daily Life	The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud).	16 weeks
Clarity - Daily Life	The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear).	16 weeks
Preferred Sound Processing Principle	The preferred sound processing principle will be assessed with the aid of a questionnaire. The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred).	16 weeks
Naturalness - Daily Life	The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural).	16 weeks
Localization - Daily Life	The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable).	16 weeks
Reverberation - Daily Life	The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant).	16 weeks
Satisfaction - Overall in Daily Life	The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).	16 weeks

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: May 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
• Other Study ID Numbers: Sonova2018_37

Drug and device information, study documents

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