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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780374
• Other study ID #: Sonova2018_37
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: May 2019
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Phonak Audéo L2M with Sound Processing Principle 1
Compensation of a hearing loss with Sound Processing Principle 1.
• Phonak Audéo L2M with Sound Processing Principle 2
Compensation of a hearing loss with Sound Processing Principle 2.
• Phonak Audéo L2M with Sound Processing Principle 3
Compensation of a hearing loss with Sound Processing Principle 3.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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