NCT04180254

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 assess strengths 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 the University Hospital of Zürich.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

November 25, 2019

Last Update Submit

September 1, 2020

Conditions

Ability, Spatial

Outcome Measures

Primary Outcomes (1)

  • Success rate of the distance discrimination

    Participants are asked whether an audio stimulus is closer or further at the end of the stimulus than at its beginning. The success rate is measured as a function of the test conditions.

    8 weeks

Study Arms (1)

Experimental: normal-hearing and hearing-impaired participants

EXPERIMENTAL

normal and hearing-impaired participants

Procedure: Effect of several processing on the auditory distance perception

Interventions

Effect of several processing on the auditory distance perceptionPROCEDURE

The focus is a comparison of hearing instrument algorithms on the auditory distance perception

Experimental: normal-hearing and hearing-impaired participants

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult persons (minimum age: 18 years)
  • Healthy outer ear (without previous surgical procedures, except cochlear implantation)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature
  • Normal hearing participants
  • Adult persons with audiometric normal hearing thresholds
  • Hearing impaired participants
  • Adult hearing impaired persons with and without (experience with) hearing aids
  • Adult hearing impaired persons with cochlear implant(s)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (4)

  • Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.

    PMID: 15035561BACKGROUND

  • Mueller MF, Meisenbacher K, Lai WK, Dillier N. Sound localization with bilateral cochlear implants in noise: how much do head movements contribute to localization? Cochlear Implants Int. 2014 Jan;15(1):36-42. doi: 10.1179/1754762813Y.0000000040. Epub 2013 Nov 25.

    PMID: 23684420BACKGROUND

  • Catic J, Santurette S, Dau T. The role of reverberation-related binaural cues in the externalization of speech. J Acoust Soc Am. 2015 Aug;138(2):1154-67. doi: 10.1121/1.4928132.

    PMID: 26328729BACKGROUND

  • Simon LS, Zacharov N, Katz BF. Perceptual attributes for the comparison of head-related transfer functions. J Acoust Soc Am. 2016 Nov;140(5):3623. doi: 10.1121/1.4966115.

    PMID: 27908072BACKGROUND

Related Links

MeSH Terms

Conditions

Spatial Navigation

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: a group of normal hearing and hearing-impaired participants
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2019

First Posted

November 27, 2019

Study Start

November 18, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

September 2, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)