NCT06986499

Brief Summary

The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities.

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 Feb 2025

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

February 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 12, 2025

Last Update Submit

May 21, 2025

Conditions

Hearing Loss, Sensorineural

Keywords

Hearing aidFreiburgerMatrix TestSSQIOI-HA

Outcome Measures

Primary Outcomes (1)

  • Oldenburg Sentence Test

    The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold in quiet and in noise. Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired.

    Estimated Time Frame 2 weeks (Test conducted at second lab session).

Secondary Outcomes (6)

  • Freiburger Monosyllabic Speech Test

    Estimated Time Frame 2 weeks (Test conducted at second lab session).

  • Match-to-Target

    Day 1 (Fitting procedure with real-ear measurements is done at first lab session)

  • Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)

    2 weeks

  • International Outcome Inventory for Hearing Aids (IOI-HA)

    2 weeks

  • Satisfaction Questionnaire

    2 weeks

  • +1 more secondary outcomes

Study Arms (1)

Comparison of Study Device with Own devices

OTHER

within subject design: compare Widex SmartRIC MRRLD 440 to subjects' own hearing aids

Device: Hearing Aid Widex SmartRIC MRRLD 440Device: Own hearing aid

Interventions

Hearing Aid Widex SmartRIC MRRLD 440DEVICE

Receiver in Canal (RIC) hearing aid

Comparison of Study Device with Own devices
Own hearing aidDEVICE

subjects' own hearing aids, any brand, any model

Comparison of Study Device with Own devices

Eligibility Criteria

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

You may qualify if:

  • Sensorineural hearing loss, mild-to-moderately severe (Pure tone average of 500, 1000, 2000 and 4000 Hz \<65).
  • Hearing loss should fall within fitting range of study hearing aid
  • Subjects should be experienced hearing aid users who have had and used hearing aids daily for at least 1 year.
  • Air-Bone-Gap should be less or equal to 20 dB.
  • Asymmetry between left and right ear should not exceed 20dB for frequencies in the range of 250Hz to 4kHz
  • Healthy (outer and middle) ear
  • Older than 18 years
  • German is mother tongue
  • Able to understand the instructions
  • Willing to participate in laboratory tests and to wear the study HAs at home for 2 weeks
  • Informed consent

You may not qualify if:

  • Contraindication for HA treatment
  • Fluctuating or rapidly progressing hearing loss
  • "Central" hearing problems
  • Limited mobility
  • Limited dexterity (in handling the HA)
  • Known psychological or cognitive problems
  • Subjects must not show any injuries or a complete perforation of the ear drum. This must be clarified prior to the beginning of the study by means of otoscopy.
  • Subjects should be in good overall medical condition (e.g., they shall not suffer from dementia) and should not use medical treatments that might affect study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hörzentrum Oldenburg gGmbH

Oldenburg, Germany, 26129, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 23, 2025

Study Start

February 25, 2025

Primary Completion

April 23, 2025

Study Completion

May 9, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)