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Completed

NCT Number: NCT04803279

Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear

The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits.

The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study.

Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016.

The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower.

The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).

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Key information

Conditions

Hearing Loss, Conductive Conductive Hearing Loss Conductive Hearing Loss, Bilateral Conductive Hearing Loss, Unilateral Ear Diseases Hearing Disability Hearing Disorders Hearing Loss Hearing Loss Mixed Hearing Loss, Mixed Conductive-Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who have consented to Section 3 of the document: "GDPR - what this means to you" (Appendix A) as part of a clinical routine visit.
  • Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
  • Adult subjects (18 years or older)
  • Patient has attended a clinical routine visit where fitting of Ponto 3 SuperPower has been performed and at least one following clinical routine visit where audiological measurements has been performed

Exclusion criteria

There are no exclusion criteria in this study due to the retrospective nature of the study.

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Treatment and study plan

Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower

Device

Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted.

Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower

Device

BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted

Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower

Device

Sound field thresholds for frequencies 500Hz, 1kHz, 2 kHz, 3kHz and 4kHz will be collected from sound field audiogram obtained as follow-up after Ponto 3 SuperPower fitting, typically this is collected 3 months post fitting, alternatively from the fitting visit. Thresholds will be obtained aided, and when available unaided

Collection of speech intelligibility scores

Device

Speech intelligibility is measured in a sound treated room using sentence tests. The sentence tests used at Norwich and Norfolk hospital is the BKB (Bamford-Kowal-Bench) and/or the The AB[s] Isophonemic Monosyllabic Word test (7).

The sentence tests are measured in quiet and/or with background speech-weighted noise.

Skin reaction

Device

Classification of skin reactions around skin penetrating implants will be made using the Holgers score. The Holgers classification is a scale from 0 to 4 that is used to grade skin reactions

Collection of Glasgow Benefit Inventory

Device

The Glasgow Benefit Inventory (GBI) contains 18 health status questions, which ask specific questions about how the health problem, in this study hearing loss, has affected their quality of life at the time the GBI is completed. In this study GBI has been collected on patients before intervention and 3 months after fitting of Ponto 3 SuperPower on abutment.

Collection of power-on usage time with Ponto 3 SuperPower

Device

Average power-on usage hours from Ponto 3 SuperPower will be collected.

Primary outcomes

  1. Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL).

    Time frame: Visit 2, 3 months

    Functional gain is the difference between the average unaided threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz and the average aided (i.e. with the Ponto 3 SuperPower) threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz.

    For bilaterally fitted patients, the best ear is selected.

Secondary outcomes

  1. Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.

    Time frame: Visit 1, Day 1

    Functional gain with Ponto 3 SuperPower, i.e. the difference between average unaided AC thresholds and aided sound field thresholds for frequencies 500, 1000, 2000, 3000 and 4000 Hz. For bilaterally fitted patients, the best ear is selected.

  2. Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL

    Time frame: Visit 2, 3 months

    Aided speech recognition (% correct words) measured in quiet and in noise with the BKB sentence test and the AB[s] short list test averaged across patients. Only participants with data for both visits were included in analysis.

  3. Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD

    Time frame: Visit 2, 3 months

    Difference in speech recognition score (%) for speech recognition in noise between unaided and aided when speech is directed to the aided ear, and noise is directed to the non-implanted ear, and when speech is directed to the non-implanted ear, and when noise is directed to the aided ear.

    Aided and unaided speech recognition (% correct words) measured with the AB[s] short list.

  4. Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.

    Time frame: visit 2, 3 months

    Effective gain with Ponto 3 SuperPower, i.e. the difference between aided sound field thresholds and the BC In-situ thresholds on the aided ear(s) measured when the Ponto 3 SuperPower(s) was fitted. The effective gain is calculated as the average (PTA4) of frequencies 500, 1000, 2000 and 4000 Hz. Only participants with data for both study visits were included in the analysis.

  5. Quality of Life Improvements With the Ponto 3 SuperPower

    Time frame: Visit 2, 3 months

    Glasgow Benefit Inventory (GBI) total score per target population.

    The GBI consists of 18 items, each on a 5 point Likert scale. Responses are scaled and averaged to give a score with a range -100 (poorest outcome) through 0 (no change) to +100 (best outcome).

  6. Individual Level Evaluation of Objectives 1-6; Improved Hearing

    Time frame: Change between visit 1 (day 1) and visit 2 (3 months)t of study

    Improved hearing was analyzed as the percentage of subjects whose performance is better or equal in the unaided to aided comparisons, i.e., have a difference ≥0.

    Functional gain was used for CHL/MHL patients and speech recognition in noise was used for SSD patients.

  7. Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL

    Time frame: Visit 1 day 1

    The difference between masked (if not available unmasked) BC and AC thresholds (unaided), denoted 'air to bone gap', calculated for frequencies 500, 1000, and 2000 Hz for the patients with CHL/MHL within indication on the implanted ear. For bilateral patients, the best ear was selected. Only participants that had complete data for these frequencies were included in the analysis.

  8. Skin Condition Assessment Around the Abutment

    Time frame: Visit 2, 3 months

    Skin condition around the abutment was assessed via Holgers score (scale 0-4).

    Holgers 0: No skin reaction Holgers 1: Redness with slight swelling Holgers 2: Redness, moistness, and moderate swelling Holgers 3: Redness, moistness, and moderate swelling with tissue granulation Holgers 4: Profound signs of infection, resulting in removal of the implant

    Only participants who had recorded Holgers score in record were analyzed.

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2021
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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