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CompletedNCT04018911

Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_20

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Sonova AG · Industry
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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 participants. These sound changing principles are enabled by respective hearing instrument technologies and 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 randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa

Conditions

Interventions

TypeNameDescription
DEVICEHearing Aid with standard Noise Reduction (NR_1)Hearing Aid with standard Noise Reduction (NR) Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle.
DEVICEHearing Aid with NR_2Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.
DEVICEHearing Aid with NR_3Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.
DRUGHearing Aid with NR_4Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. This experimental condition combines standard NR and novel NR principle to result in different degrees of noise suppression and good speech quality.

Timeline

Start date
2019-06-03
Primary completion
2019-08-19
Completion
2019-09-16
First posted
2019-07-15
Last updated
2019-10-11

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04018911. Inclusion in this directory is not an endorsement.