Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Primary Purpose
Hearing Loss, Conductive, Hearing Loss, Mixed
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Audiometry
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss, Conductive focused on measuring Hearing loss, hearing disorder,, ear diseases, BAHS
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent Form
- 12 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
Exclusion Criteria:
- 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
Sites / Locations
- Aalborg University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
B. To assess the improvement of hearing with the Ponto 4 on the implanted ear(s).
1. Functional gain with Ponto 4, i.e. the difference between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
C. To assess the improvement of speech recognition with Ponto 4 on the implanted ear(s).
Difference in speech recognition score in percent between unaided and aided, assessed in quiet.
G. To assess the degree to which the Ponto 4 compensates for the BC hearing loss on the implanted ear(s).
Effective gain defined as the difference in dB between aided sound field thresholds with Ponto 4, and BC In-situ thresholds on the aided ear(s) measured at the time of the fitting of Ponto 4(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Effective gain with Ponto 4, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
H. To evaluate the above objectives on individual levels
1. Endpoints A1, B1, C1 analyzed as the proportion of subjects whose performance is better or equal in the unaided to aided comparisons, i.e. have a difference ≥0
I. To assess the degree of inner ear hearing loss degradation on the implanted ear(s) (for SSD the stimulated ear).
1. Hearing loss degradation is the difference in dB between masked (if not available unmasked) BC thresholds obtained at the study visit, and at the visit when Ponto 4(s) was fitted
J. To assess if a patient's with CHL/MHL hearing loss has degraded to being outside fitting range on the implanted ear(s).
1. BC hearing loss (PTA4), measured at the study visit, being outside intended fitting range (PTA4 >45 dB HL) compared to being inside fitting range (PTA<45 dB HL) at the time of the study visit.
K. To asses if patients' with CHL/MHL air to bone gap (PTA4) has increased/decreased on the implanted ear(s)
1. The difference between masked (if not available unmasked) BC and AC thresholds, denoted 'air to bone gap', calculated for frequencis 500, 1000, 2000 and 4000 Hz from audiogram measured at the study visit and the fitting visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04761926
Brief Title
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Official Title
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a prospective, 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Conductive, Hearing Loss, Mixed
Keywords
Hearing loss, hearing disorder,, ear diseases, BAHS
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Intervention Type
Device
Intervention Name(s)
Audiometry
Other Intervention Name(s)
Speach recognition in quiet, Sound field audiometry, Patient reported outcomes
Intervention Description
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.
Primary Outcome Measure Information:
Title
To investigate the improvement in hearing with the Ponto 4 (s) on the implanted ear for patients within intended use.
Description
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.
Time Frame
Visit 1, Day 1
Secondary Outcome Measure Information:
Title
B. To assess the improvement of hearing with the Ponto 4 on the implanted ear(s).
Description
1. Functional gain with Ponto 4, i.e. the difference between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Time Frame
Visit 1, Day 1
Title
C. To assess the improvement of speech recognition with Ponto 4 on the implanted ear(s).
Description
Difference in speech recognition score in percent between unaided and aided, assessed in quiet.
Time Frame
Visit 1,Day 1
Title
G. To assess the degree to which the Ponto 4 compensates for the BC hearing loss on the implanted ear(s).
Description
Effective gain defined as the difference in dB between aided sound field thresholds with Ponto 4, and BC In-situ thresholds on the aided ear(s) measured at the time of the fitting of Ponto 4(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Effective gain with Ponto 4, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time Frame
After study completion, 6 months
Title
H. To evaluate the above objectives on individual levels
Description
1. Endpoints A1, B1, C1 analyzed as the proportion of subjects whose performance is better or equal in the unaided to aided comparisons, i.e. have a difference ≥0
Time Frame
After study completion, 6 months
Title
I. To assess the degree of inner ear hearing loss degradation on the implanted ear(s) (for SSD the stimulated ear).
Description
1. Hearing loss degradation is the difference in dB between masked (if not available unmasked) BC thresholds obtained at the study visit, and at the visit when Ponto 4(s) was fitted
Time Frame
After study completion, 6 months
Title
J. To assess if a patient's with CHL/MHL hearing loss has degraded to being outside fitting range on the implanted ear(s).
Description
1. BC hearing loss (PTA4), measured at the study visit, being outside intended fitting range (PTA4 >45 dB HL) compared to being inside fitting range (PTA<45 dB HL) at the time of the study visit.
Time Frame
After study completion, 6 months
Title
K. To asses if patients' with CHL/MHL air to bone gap (PTA4) has increased/decreased on the implanted ear(s)
Description
1. The difference between masked (if not available unmasked) BC and AC thresholds, denoted 'air to bone gap', calculated for frequencis 500, 1000, 2000 and 4000 Hz from audiogram measured at the study visit and the fitting visit.
Time Frame
After study completion, 6 moths
Other Pre-specified Outcome Measures:
Title
L. To assess the usage and performance of connectivity device(s)
Description
1. Questionnaire: Self-reported usage, usage hours and satisfaction ratings 0-10, for connectivity device(s) previously given to the test subject, where 0 is "very unsatisfied" and 10 is "very satisfied".
Time Frame
Visit 1, Day 1
Title
F. To assess the usage time with Ponto 4.
Description
Questionnaire: Self-reported usage hours per day during the month prior to the study visit across all subjects.
Self-reported usage hours per day analyzed separately for subjects with conductive/mixed hearing loss and single sided deafness (SSD).
Time Frame
Visit 1, Day 1
Title
E. To assess the quality of life of the Ponto 4
Description
GHSI Questionnaire: Scores across all subjects, on a subjective 0-5 likert scale
Time Frame
Visit 1, Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week)
Title
D. To assess the subjective experience of the Ponto 4
Description
SSQ Questionnaire: Scores across all subjects, on a subjective scale from 0-10, where 0 is "the worst" and 10 is "the best"
Time Frame
Visit 1,Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent Form
12 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris L Jacobsen, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
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