NCT03108768

Brief Summary

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

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

March 31, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

March 31, 2017

Last Update Submit

June 15, 2017

Conditions

Hearing Loss, Bilateral Sensorineural, Progressive

Outcome Measures

Primary Outcomes (1)

  • Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)

    The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test. The result is the signal to noise ratio in dB (dB SNR). Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.

    Three weeks

Secondary Outcomes (2)

  • Speech intelligibility in percent in a quiet listening situation

    One week

  • Zero-defect performance in daily life

    Three weeks

Study Arms (2)

Successor of Phonak Virto V

EXPERIMENTAL

The successor of Phonak's Virto V will be fitted to the participants individual hearing loss.

Device: Hearing Aid (Successor of Phonak Virto V)

Phonak Virto V

ACTIVE COMPARATOR

Phonak Virto V will be fitted to the participants individual hearing loss.

Device: Hearing Aid (Phonak Virto V)

Interventions

Hearing Aid (Successor of Phonak Virto V)DEVICE

The successor of Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.

Successor of Phonak Virto V
Hearing Aid (Phonak Virto V)DEVICE

Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.

Phonak Virto V

Eligibility Criteria

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

You may qualify if:

  • Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Ability to fill in a questionnaire (p/eCRF) 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 in Stäfa (Switzerland)
  • 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
  • Central hearing disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonova AG

Stäfa, Canton of Zurich, 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Phonak Virto V and the successor of Phonak Virto V will be fitted to the participants individual hearing loss.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 11, 2017

Study Start

April 3, 2017

Primary Completion

June 14, 2017

Study Completion

June 14, 2017

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)