MedTrace Logo

Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid

NCT04761926 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-31

Study results available
· View outcomes & findings →

Summary

The study is a combined retrospective (fitting visit) and prospective (study visit), multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019.

Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics.

The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.

Conditions

  • Hearing Loss, Conductive
  • Hearing Loss, Mixed

Interventions

DEVICE

Audiometry

Audiometry: Thresholds from the audiogram obtained when Ponto 4 were fitted. Pure tone air conduction (AC) and bone conduction (BC) audiometry conducted at the visit. Speech recognition in quiet: Speech intelligibility is measured in a soundproof room using the Matrix sentences presented from a loudspeaker. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. This test will be obtained both unaided and aided (with and without the Ponto 4(s)). Sound field Audiometry: Detection of sound field thresholds presented from a loudspeaker. Thresholds will be obtained both unaided and aided and the test order will be balanced between subjects. During these measurements, the Ponto 4 will be programmed in omni-directional mode, with noise reduction and feedback management system turned off.

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Chris L Jacobsen, MD · Aalborg University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-02-24
Completion
2021-02-24

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04761926 on ClinicalTrials.gov