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

NCT04761926 | Completed Results

• 1 other identifier: BC110
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed

Keywords

Hearing loss; hearing disorder,; ear diseases; BAHS

Outcome Measures

Primary Outcomes (1)

• To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use.

  Functional gain with Ponto 4, i.e. the difference between average unaided and aided sound field thresholds. The functional gain (PTA4) is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz.

  The outcome measure was assessed during Study Visit 1 (Day 1).

Secondary Outcomes (7)

• B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).

  The outcome measure was assessed during Study Visit 1 (Day 1).

• C. To Assess the Improvement of Speech Recognition With Ponto 4 on the Implanted Ear(s).

  The outcome measure was assessed during Study Visit 1 (Day 1).

• G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).

  The assessment for this outcome measure was based on the BC in situ test conducted during a visit at least 6 weeks prior to Study Visit 1 (data collected retrospectively), and an aided sound field thresholds test conducted on Study Visit Day 1.

• H. To Evaluate the Above Objectives on Individual Levels

  The outcome measure was assessed during Study Visit 1 (Day 1).

• I. To Assess the Degree of Inner Ear Hearing Loss Degradation on the Implanted Ear(s) (for SSD the Stimulated Ear).

  Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1).

Other Outcomes (4)

• L. To Assess the Usage and Performance of Connectivity Device(s)

  Visit 1, Day 1

• F. To Assess the Usage Time With Ponto 4.

  Visit 1, Day 1

• E. To Assess the Quality of Life of the Ponto 4

  Visit 1, Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week)

Study Arms (1)

single arm

EXPERIMENTAL

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

Device: Audiometry

Interventions

Audiometry 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.

Also known as: Speach recognition in quiet, Sound field audiometry, Patient reported outcomes

single arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• years old and above
• 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
• Fluent in local language, as judged by the investigator

You may not qualify if:

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

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases

Interventions

Audiometry; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Results Point of Contact

• Title: Nicole Amichetti, PhD
• Organization: Oticon Medical

nitc@oticonmedical.com

6093660424

Study Officials

• Chris L Jacobsen, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 20, 2021
• First Posted: February 21, 2021
• Study Start: January 15, 2021
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)