Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2

NCT ID: NCT03774030

Last Updated: 2019-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2019-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ability, Spatial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

a group of hearing-impaired particpants with mild or severe hearing loss
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hearing impaired participants

Hearing impaired participants with mild or severe hearing loss

Group Type EXPERIMENTAL

several virtual 3-D complex audio environments

Intervention Type PROCEDURE

The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

several virtual 3-D complex audio environments

The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult persons (minimum age: 18 years) with Hearing loss
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Swiss Commission for Technology and Innovation

OTHER

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Norbert Dillier, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 15035561 (View on PubMed)

Choisel S, Wickelmaier F. Evaluation of multichannel reproduced sound: scaling auditory attributes underlying listener preference. J Acoust Soc Am. 2007 Jan;121(1):388-400. doi: 10.1121/1.2385043.

Reference Type RESULT
PMID: 17297794 (View on PubMed)

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.

Reference Type RESULT
PMID: 23684420 (View on PubMed)

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.

Reference Type RESULT
PMID: 26328729 (View on PubMed)

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.

Reference Type RESULT
PMID: 27908072 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-02051-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.