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

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: NCT04018911
• Other study ID #: Sonova2019_20
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: September 16, 2019

Study information

• Verified date: October 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 16, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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 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

• Massively limited dexterity

• Known psychological problems

• Known central hearing disorders

• colour blinded

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Hearing 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.
• Hearing Aid with NR_2
Each 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.
• Hearing Aid with NR_3
Each 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.

Drug:
• Hearing Aid with NR_4
Each 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.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Non-verbal Trail Making Test A & B	The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The data, serving as an outcome measure, are time-to-complete the set in seconds.	1 week
Other	color-word-interference test by J.R.Stroop	The color-word- interference test ("Farb-Wort-Interferenztest nach J.R.Stroop" (version: "Günther Bäumler")) is a neuropsychological test of visual attention and interferer suppression and will be carried out in the laboratory. In the first trial, the subject has to read the names of colours written on a card as fast and accurately as possible. In the second trial, the subject has to name the colour ink of filled boxes on a card as quickly and accurately as possible. In the third trial, the names of colours are written on a card in a dissimilarly coloured ink. The participant must read aloud the written words, whilst ignoring the colour of the ink. The data, serving as an outcome measure, are time-to-complete the sets in seconds.	1 week
Primary	sound quality ratings	The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. The data, serving as the primary outcome measure, are collected in the laboratory and will use a continuous rating scale. The scale ranges from 0 "very bad" to 100 "very good" in increments of 1.	4 weeks
Secondary	Oldenburg sentence test & reaction time task	A dual task paradigm will be used in which the Oldenburg Sentence test in noise will be administered as a primary task, and the subject will press a button as fast as possible when a light appears on a screen as a secondary task. The aim is to recall as many words from the presented sentence at a predefined SNR and press the button as fast as possible at the same time. The data derived, serving as secondary outcome measure are he Signal to noise ratio (SNR) in decibel (dB) where a 50% speech reception threshold is reached and the reaction time (RT) in seconds and the number of missed stimuli. and number of false alarms missed data rate.	3 weeks
Secondary	Oldenburg Sentence test (Olsa)	Oldenburg Sentence test in noise will be administered as single task. The aim is to recall as many words from the presented sentence at different signal to noise ratios until the 50% threshold is reached. The data derived, serving as secondary outcome measure are the Signal to noise ratio (SNR) in decibel (dB) where a 50% speech reception threshold is reached.	4 weeks
Secondary	Adaptive Categorial Listening Effort Scaling (ACALES)	The ACALES procedure determines self-reported individual listening effort on a scale from "extreme effort" to "no effort" within a signal-to-noise ratio range that corresponds to individual subject perceptions.; The data, serving as a secondary outcome, are a set of points on a categorial scale (subjectively perceived listening effort) as a function of different SNRs.	3 weeks
Secondary	qualitative interview form	A qualitative questionnaire with predefined questions and comment sections to gather information on individual perceptions regarding the 3 experimental conditions to the active comparator ( see study arms/ interventions for detailed descriptions) during different laboratory-based complex acoustic scenes. The data collected from this questionnaire are scores on a continuous rating scale ranging from "0" (worst) to "10"( best).	3 weeks