Quest Sound Recover (SR2) vs. Venture SR2

Hearing Loss Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895477
• Other study ID #: Sonova2016_10
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: January 27, 2017
• Start date: July 2016
• Est. completion date: January 20, 2017

Study information

• Verified date: January 2017
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform.

To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 20, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature (Appendix Informed Consent Form)

• Ability to fill in a question conscientious

• Healthy outer ear (w/o previous surgical procedures)

• Sensorineural symmetric hearing loss (HL)

• N4 to N7 (degree of HL)

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

• Limited ability to describe listening impressions/experiences and the use of the hearing aid

• Inability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist

• Massively limited dexterity

• Known Psychological problems

• Central hearing problems

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• hearing aid

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional gain	Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.	after 2 weeks
Primary	Phoneme Perception Test	Change of Detection thresholds after 4 weeks hearing instrument wearing time	after 2
Primary	Functional gain	Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.	after 8 weeks
Primary	Phoneme Perception Test	Change of detection thresholds after 4 weeks hearing instrument wearing time	after 8 weeks
Secondary	sound quality ratings		after 6 and 12 weeks
Secondary	questionnaires		after 2, 6, 8 and 12 weeks