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

NCT ID: NCT04761926

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-02-24

Brief 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.

Detailed Description

This is a post market clinical follow up (PMCF) study with the purpose of gather knowledge on the use and performance of the Ponto 4 device on existing Ponto 4 users. The study does not include any treatment or fitting of new devices, instead the real-life application of the use of Ponto 4 on subjects already using Ponto 4(s) are investigated.

The Investigational Device used in the study is Ponto 4, a CE marked, and FDA cleared bone anchored hearing solution, produced by Oticon Medical AB and commercially available since June 2019.

The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 4 device as a minimum 1.5 month prior to the study. 20 patients, including minors down to 12 years old, with a conductive, mixed hearing loss or single-sided deafness will be included. The rationale for including minors is that they are also users of the device, and it is found important to collect data from their experience of using the device as well.

The study is a retrospective and prospective, multi-center study. It has one visit of 2,5-3 hours for adult subjects ≥18 years old. To minimize the burden and risks of tiredness for the minor subjects from 12-17 years old, the protocol activities can be divided into two visits. The decision will be based on the Investigators discretion.

The majority of the objectives of the study are prospectively collected whereas the BC In-situ (hearing with the Ponto 4 on) and audiometric data from the time of the fitting of Ponto 4, are collected retrospectively from the time of the fitting of Ponto 4 (aka the fitting visit).

The overall objectives of the study are to investigate the improvement in hearing with the Ponto 4(s) on the implanted ear(s), in terms of the subject's ability to hear sounds and understand speech when using the device.

The primary endpoint is to investigate the improvement in hearing with the Ponto 4(s) on the implanted ear for patients within intended use.

These will be evaluated through a hearing and a speech test, both assessing the hearing with the Ponto 4(s) both on and off. Additionally, the subject will complete 2 patient reported outcome, report daily usage time of the device and assess satisfaction of connectivity devices.

Minimal risks are expected for subjects participating in the study. 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 measurements will require an extra effort and may be found slightly tiring by the subject. To mitigate the risk of tiredness the subject will be given the opportunity to have breaks during the visit.

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

single arm

Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).

Group Type: EXPERIMENTAL

Audiometry

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Speach recognition in quiet; Sound field audiometry; Patient reported outcomes

Eligibility Criteria

Inclusion Criteria

1. Signed Informed Consent Form

2. 12 years old and above

3. Subjects with hearing loss fitted unilaterally or bilaterally with the Ponto 4(s) on abutment at least 1.5 months prior to being enrolled in the study

4. Fluent in local language, as judged by the investigator

Exclusion Criteria

1. Participation in another clinical investigation which might cause interference with study participation.

2. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete patient related outcome (PRO's) according to investigators discretion

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oticon Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris L Jacobsen, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BC110

Identifier Type: -

Identifier Source: org_study_id