Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_12

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

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Hearing Aid without NR; Device: Hearing Aid with NR_A; Device: Hearing Aid with NR_B; Device: Hearing Aid with NR_C

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Stäfa, Switzerland, 8712
    • Sonova AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hearing Aid without NR; Hearing Aid without Noise Reduction (NR) serves as reference condition.	Device: Hearing Aid without 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. 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.; Other Names: NR: Noise Reduction
Experimental: Hearing Aid with NR_A; NR_A: Noise Reduction principle A	Device: Hearing Aid with NR_A; 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 vary in their parametrization to result in different degrees of noise suppression and good speech quality.; Other Names: NR_A: Noise Reduction principle A
Experimental: Hearing Aid with NR_B; NR_B: Noise Reduction principle B.	Device: Hearing Aid with NR_B; 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 vary in their parametrization to result in different degrees of noise suppression and good speech quality.; Other Names: NR_B: Noise Reduction principle B
Experimental: Hearing Aid with NR_C; NR_C: Noise Reduction principle C.	Device: Hearing Aid with NR_C; 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 vary in their parametrization to result in different degrees of noise suppression and good speech quality.; Other Names: NR_C: Noise Reduction principle C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oldenburg sentence test in noise	The data, serving as secondary outcome is a Signal to noise ratio (SNR) in decibel (dB) where a 50% speech reception threshold is reached. This outcome measurement will be carried out in the laboratory.	4 weeks
Oldenburg sentence test & manual tracking 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 manually track a point on a computerised elliptical track as a secondary task. The aim is to recall as many words from the presented sentence at a predefined SNR and track the point as accurately as possible at the same time. The SNR is set as the level at which a subject reaches a speech reception threshold of 80-90%. The data derived, serving as a secondary outcome measure, are a [%] of time on target and distance error from the target.	4 weeks
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.	2 weeks
Self-report form	A qualitative questionnaire with predefined questions and comment sections to gather information on individual perceptions regarding the comparison of two different hearing programs during different laboratory-based acoustic scenes. For details of the hearing aid settings, see study arms. The data collected from this questionnaire are scores on a continuous rating scale ranging from "hearing program A is much worse than hearing program B" to "hearing program B is much better than hearing program A" and any subjective comments given.	One week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interaural Phase Difference (IPD) Detection thresholds	A 2 Interval - 2 Alternative Forced Choice task to measure the psychometric function of IPD detection with changing stimulus frequency. The data, serving as an outcome measure, is the individual interaural phase difference (IPD) frequency threshold (the frequency up to which 75% correct answers are given).	1 week
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
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

Collaborators and Investigators

• Sponsor: Sonova AG
• Investigators: Principal Investigator: Juliane Raether, Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: Sonova2018_12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No