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

Conductive Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803279
• Other study ID #: BC107
• Status: Recruiting
• Start date: March 16, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: March 2021
• Source: Oticon Medical
• Contact: liselotte borup
• Phone: +45 41241964
• Email: liselotteborup[@]yahoo.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: May 31, 2021
• Est. primary completion date: May 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

-

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Conductive Hearing Loss, Bilateral
• Conductive Hearing Loss, Unilateral
• Deafness
• Ear Diseases
• Hearing Disability
• Hearing Loss
• Hearing Loss Mixed
• Hearing Loss, Bilateral
• Hearing Loss, Conductive
• Hearing Loss, Unilateral

Intervention

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.
• 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
• 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
• 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.
• 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
• 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.
• Collection of power-on usage time with Ponto 3 SuperPower
Average power-on usage hours from Ponto 3 SuperPower will be collected.

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	To assess the skin condition around the abutment	Holgers score (scale 0-4)	Visit 2, 3 months