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).

Study Overview

• Status: Recruiting
• Conditions: Ear Diseases; Hearing Loss, Conductive; Hearing Loss Mixed; Hearing Disability; Conductive Hearing Loss; Conductive Hearing Loss, Bilateral; Conductive Hearing Loss, Unilateral
• Intervention / Treatment: Device: Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower; Device: Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower; Device: Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower; Device: Collection of speech intelligibility scores; Device: Skin reaction; Device: Collection of Glasgow Benefit Inventory; Device: Collection of power-on usage time with Ponto 3 SuperPower

• Study Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

• Study Contact: Name: liselotte borup; Phone Number: +45 41241964; Email: liselotteborup@yahoo.dk

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Recruiting
      • Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Contact: John FitzGerald, PI; Phone Number: 0044-1603 288910; Email: john.fitzgerald@nnuh.nhs.uk
      • Contact: Amanda Collet; Phone Number: 0044-1603289729; Email: amanda.collett@nnuh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Data will be collected from patients, who are Ponto 3 SuperPower users, and who have attended the Audiiology Clinic at Norfolk and Norwich University Hospital (NNUH),Colney Ln, Norwich NR4 7UY, UK, in the period 2016-2020

Description

Inclusion Criteria:

1. 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.
2. Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
3. Adult subjects (18 years or older)
4. 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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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Ponto 3 SuperPower users; Patients who are fitted either unilaterlaly or bilatterally on abutment since the device came to the market in 2016, and who have follwoed the clinics normal routine fitting and follow up visits. They must also have undergone the normal procedures performed as part of the clinics routine for fitting and following up. Data will be collected from these routine visits.

Device: Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower; Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted.; Device: Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower; BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted; Device: Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower; 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; Device: Collection of speech intelligibility scores; 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.; Device: Skin reaction; 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; Device: Collection of Glasgow Benefit Inventory; 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.; Device: Collection of power-on usage time with Ponto 3 SuperPower; Average power-on usage hours from Ponto 3 SuperPower will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the improvement in hearing with the Ponto 3 SuperPower for patients with CHL/MHL.	Functional gain with Ponto 3 SuperPower, i.e. the difference between average unaided AC thresholds and aided sound field thresholds as the average (PTA4) of frequencies 500, 1000, 2000 and 4000 Hz	Visit 2, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the improvement in hearing with the Ponto 3 SuperPower for patients with CHL/MHL.	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	Visit 1, Day 1
To assess the improvement of speech recognition in quiet and in noise with Ponto 3 SuperPower on the implanted ear(s) for patients with CHL/MHL	Difference in speech recognition (%) for speech recognition in quiet between unaided and aided.; Difference in speech recognition (%) for speech recognition in noise between unaided and aided.	Visit 2, 3 months
To assess the speech recognition in noise with Ponto 3 SuperPower on for patients with SSD	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.	Visit 2, 3 months
To assess the degree to which the Ponto 3 SuperPower compensates for the BC hearing loss on the implanted ear(s) for patients with CHL/MHL.	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.	After study completion, 6 months
To assess the quality of life with the Ponto 3 SuperPower	Collected summarised scores from the questionnaire Glasgow Benefit Inventory (GBI)	Visit 2, 3 months
To evaluate the above objectives on individual levels	First 4 mentioned endpoints analyzed as the proportion of subjects whose performance is better or equal in the unaided to aided comparisons, i.e. have a difference ≥0	After study completion, 6 months
To assess the air to bone gap (PTA4) on the implanted ear(s) for patients with CHL/MHL	The difference between masked (if not available unmasked) BC and AC thresholds, denoted 'air to bone gap', calculated for frequencies 500, 1000 and 2000 Hz from audiogram measured in connection with the fitting of Ponto 3 SuperPower	After study completion, 6 months
To assess the skin condition around the abutment	Holgers score (scale 0-4)	Visit 2, 3 months

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: John E FitzGerald, Bsc Phd, Norfolk & Norwich University Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Anticipated): May 16, 2021
• Study Completion (Anticipated): May 31, 2021

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Bilateral; Hearing Loss, Conductive; Ear Diseases; Hearing Loss, Unilateral
• Other Study ID Numbers: BC107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No