Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34

NCT03755453 | Completed

• 1 other identifier: Sonova2018_34
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Comparison of fitting method A versus B in regard to sound quality

  The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method.

  2 months

Secondary Outcomes (1)

• Comparison of fitting method A versus B in regard to speech intelligibility in noise

  2 months

Study Arms (2)

Audéo B-Direct fitted with fitting method A

ACTIVE COMPARATOR

Traditional standard fitting method which do not include adjustments from the participants.

Device: Hearing aid: Phonak Audéo B90-Direct

Audéo B-Direct fitted with fitting method B

EXPERIMENTAL

Alternative fitting method which includes additional adjustments from the participants.

Device: Hearing aid: Phonak Audéo B90-Direct

Interventions

Hearing aid: Phonak Audéo B90-Direct DEVICE

Hearing aids will be fitted to the participants individual hearing loss.

Audéo B-Direct fitted with fitting method A; Audéo B-Direct fitted with fitting method B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (p/eCRF) conscientiously
• Informed Consent as documented by signature

You may not qualify if:

• 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 appointments
• Limited ability to describe listening impressions or to use hearing aids/ accessories
• Inability to produce a reliable hearing test result
• Massively limited dexterity
• Known psychological problems
• Known central hearing disorders

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: November 28, 2018
• Study Start: October 11, 2018
• Primary Completion: January 31, 2019
• Study Completion: February 28, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)