About this trial
A methodical evaluation of 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). Objective laboratory measurements as well as subjective ratings 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 Stäfa.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Good written and spoken German language skills
No suffering from any speech disorders
Experienced hearing aid user (min. 6 months)
Ability to stand and walk during the experiment
Disqualifiers
Contraindications to the medical device
Unaidable hearing loss in one or both ears
Acute tinnitus (in either one ear and occurrence for less than 3 months)
Anatomical deformity of one or both ears
Trial design
Crossover
Treatments tested in this trial
Hearing Aid with standard noise reduction (NR_1)
DeviceEach participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 to mimic the natural directivity of the outer ear.
Hearing Aid with NR_2
DeviceEach participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Hearing Aid with NR_3
DeviceEach participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Treatment groups
Trial outcomes
Primary outcomes
Own Voice Level
Changes to the participants' own voice level (RMS in dB) during a conversation in noise in the laboratory will be recorded in each interventional condition.
Secondary outcomes
Interpersonal distance
Changes to the participants' interpersonal distance (in m) during a conversation in noise in the laboratory will be measured in each interventional condition.
Qualitative interview form
A qualitative questionnaire with predefined questions to gather individual perceptions regarding the 3 interventional conditions during a conversation in noise in the laboratory. The data collected from this questionnaire are scores on a rating scale from "0" (worst) to "5" (best) in increments of 1.
Sponsors and contacts
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Sebastian Griepentrog
Lead sponsor
Sonova AG
Sponsor institution
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