NCT03554577

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

May 28, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2018

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

May 7, 2018

Last Update Submit

November 15, 2018

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Oldenburg sentence test in noise

    4 weeks

  • Oldenburg sentence test & manual tracking task

    4 weeks

  • Adaptive Categorial Listening Effort Scaling (ACALES)

    2 weeks

  • Self-report form

    One week

Other Outcomes (3)

  • Interaural Phase Difference (IPD) Detection thresholds

    1 week

  • Non-verbal Trail Making Test A & B

    1 week

  • color-word-interference test by J.R.Stroop

    1 week

Study Arms (4)

Hearing Aid without NR

ACTIVE COMPARATOR

Hearing Aid without Noise Reduction (NR) serves as reference condition.

Device: Hearing Aid without NR

Hearing Aid with NR_A

EXPERIMENTAL

NR\_A: Noise Reduction principle A

Device: Hearing Aid with NR_A

Hearing Aid with NR_B

EXPERIMENTAL

NR\_B: Noise Reduction principle B.

Device: Hearing Aid with NR_B

Hearing Aid with NR_C

EXPERIMENTAL

NR\_C: Noise Reduction principle C.

Device: Hearing Aid with NR_C

Interventions

Hearing Aid without NRDEVICE

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.

Also known as: NR: Noise Reduction
Hearing Aid without NR
Hearing Aid with NR_ADEVICE

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.

Also known as: NR_A: Noise Reduction principle A
Hearing Aid with NR_A
Hearing Aid with NR_BDEVICE

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.

Also known as: NR_B: Noise Reduction principle B
Hearing Aid with NR_B
Hearing Aid with NR_CDEVICE

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.

Also known as: NR_C: Noise Reduction principle C
Hearing Aid with NR_C

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonova AG

Stäfa, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Officials

  • Juliane Raether

    Sonova AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each participant will be treated with each sound changing principle (Noise Reduction principle (NR)) in a randomized order.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 13, 2018

Study Start

May 28, 2018

Primary Completion

August 31, 2018

Study Completion

October 2, 2018

Last Updated

November 16, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)