NCT02303210

Brief Summary

The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

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

First Submitted

Initial submission to the registry

November 3, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

November 3, 2014

Last Update Submit

September 20, 2017

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test.

    6 months

Study Arms (2)

hearing aid NaidaUP

OTHER

Within subject design: compare frequency lowering one with frequency lowering two.

Device: hearing aid NaidaUP

hearing aid NaidaSP

OTHER

Within subject design: compare frequency lowering one with frequency lowering two.

Device: hearing aid NaidaSP

Interventions

hearing aid NaidaUPDEVICE

Standard Power Hearing instruments including different frequency lowering techniques

hearing aid NaidaUP
hearing aid NaidaSPDEVICE

Standard Power Hearing instruments including different frequency lowering techniques

hearing aid NaidaSP

Eligibility Criteria

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

You may qualify if:

  • female and male adults (\>18 years old)
  • mild to severe Hearing Loss
  • symmetric Hearing Loss
  • german native speakers

You may not qualify if:

  • persons who are not able to attend multiple appointments
  • persons who are not able to handle a hearing aid
  • persons with a mental handicap
  • persons with limited access to multiple hearing situations
  • persons with psychological disease
  • no acclimatization to hearing aids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoerzentrum Oldenburg

Oldenburg, Lower Saxony, 26129, Germany

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Julia Rehmann, B.Sc.

    Phonak AG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 27, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

National Regulations do not require to share data,

Locations

DE(1)