NCT02740023

Brief Summary

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

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 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

2 months

First QC Date

March 31, 2016

Last Update Submit

June 20, 2018

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Speech intelligibility in percent in a quiet listening situation

    The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the german rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo). The result is the speech intelligibility in percent. 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.

    One week

Secondary Outcomes (1)

  • Speech intelligibility in percent in a noisy listening situation

    One week

Other Outcomes (2)

  • Initial first fit acceptance (pre-calulation) in lab

    One week

  • Sound quality and listening effort ratings in lab

    Four weeks

Study Arms (2)

Phonak Audéo V90-13

ACTIVE COMPARATOR

The Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.

Device: Hearing Aid (Phonak Audéo V90-13)

Successor of Phonak Audéo V90-13

EXPERIMENTAL

The successor of Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.

Device: Hearing Aid (Successor of Phonak Audéo V90-13)

Interventions

Hearing Aid (Phonak Audéo V90-13)DEVICE

Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.

Phonak Audéo V90-13
Hearing Aid (Successor of Phonak Audéo V90-13)DEVICE

The successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.

Successor of Phonak Audéo V90-13

Eligibility Criteria

Age18 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
  • 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 15, 2016

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)