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

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Hearing Aid with NR_2; Device: Hearing Aid with NR_3; Drug: Hearing Aid with NR_4; Device: Hearing Aid with standard Noise Reduction (NR_1)

• Registration Number: NCT04018911
• Lead Sponsor: Sonova AG

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-03
• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-15
• Primary Completion: 2019-08-19
• Study Completion: 2019-09-16
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hearing Aid with NR_2	Hearing Aid with NR_2	NR_2: Noise Reduction principle 2
Hearing Aid with NR_3	Hearing Aid with NR_3	NR_3: Noise Reduction principle 3
Hearing Aid with NR_4	Hearing Aid with NR_4	NR_4: Noise Reduction principle 4
Hearing Aid standard NR_1	Hearing Aid with standard Noise Reduction (NR_1)	Hearing Aid with standard Noise Reduction (NR) serves as reference condition.

Primary Outcome Measures

Name	Time	Method
sound quality ratings	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Oldenburg sentence test & reaction time task	3 weeks	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.
Oldenburg Sentence test (Olsa)	4 weeks	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.
Adaptive Categorial Listening Effort Scaling (ACALES)	3 weeks	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.
qualitative interview form	3 weeks	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).

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Switzerland