Trial Outcomes & Findings for Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid (NCT NCT04761926)
NCT ID: NCT04761926
Last Updated: 2025-07-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
The outcome measure was assessed during Study Visit 1 (Day 1).
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
Ponto 4 Sound Processor Users
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ponto 4 Sound Processor Users
n=20 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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Age, Categorical
<=18 years
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0 Participants
n=20 Participants
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Age, Categorical
Between 18 and 65 years
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13 Participants
n=20 Participants
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Age, Categorical
>=65 years
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7 Participants
n=20 Participants
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Age, Continuous
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56.1 years
STANDARD_DEVIATION 17.6 • n=20 Participants
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Sex: Female, Male
Female
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9 Participants
n=20 Participants
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Sex: Female, Male
Male
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11 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: The outcome measure was assessed during Study Visit 1 (Day 1).Population: only 18 subjects had measurable thresholds for all 4 frequencies to be calculated for the PTA4 of functional gain.
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.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=18 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use.
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31.5 [dB]
Standard Deviation 9.5
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SECONDARY outcome
Timeframe: The outcome measure was assessed during Study Visit 1 (Day 1).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.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=19 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).
6000Hz
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22.7 [dB]
Standard Deviation 10.2
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B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).
8000Hz
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22.1 [dB]
Standard Deviation 12.3
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B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).
250Hz
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14.2 [dB]
Standard Deviation 9.9
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B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).
500Hz
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28.7 [dB]
Standard Deviation 12.0
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B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).
1000Hz
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36.6 [dB]
Standard Deviation 9.9
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B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).
2000Hz
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28.6 [dB]
Standard Deviation 13.8
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B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).
3000Hz
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32.9 [dB]
Standard Deviation 11.6
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B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s).
4000Hz
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32.8 [dB]
Standard Deviation 8.6
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SECONDARY outcome
Timeframe: The outcome measure was assessed during Study Visit 1 (Day 1).Difference in speech recognition score in percent between unaided and aided, assessed in quiet. Speech recognition was measured in free field using the Matrix sentences test. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A formula selects a word from a category (name, verb, number, adjective and noun) and creates a five-word sentence. A word from each category is chosen at random to create the sentence. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. Speech was presented from a loudspeaker 1 meter in front of the subject (0 degree azimuth). The speech signal was fixed at 65 dB SPL (C-weighted). The subject had to repeat as many words as possible after each sentence. For the aided condition, Ponto 4 was tested in the subject's user settings. The test order of aided and unaided condition was balanced across subjects.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=19 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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C. To Assess the Improvement of Speech Recognition With Ponto 4 on the Implanted Ear(s).
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55.9 percentage points (% points)
Standard Deviation 31.7
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SECONDARY outcome
Timeframe: 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.Population: Ponto 4 Sound Processor Users
1\. 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.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=14 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).
250Hz
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22.0 dB
Standard Deviation 7.3
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G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).
500Hz
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7.14 dB
Standard Deviation 7.84
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G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).
1000Hz
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3.21 dB
Standard Deviation 7.69
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G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).
2000Hz
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2.86 dB
Standard Deviation 8.25
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G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).
3000Hz
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10.20 dB
Standard Deviation 7.0
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G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).
4000Hz
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13.8 dB
Standard Deviation 7.1
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G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).
6000Hz
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17.0 dB
Standard Deviation 9.4
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G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s).
8000Hz
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12.3 dB
Standard Deviation 9.7
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SECONDARY outcome
Timeframe: The outcome measure was assessed during Study Visit 1 (Day 1).Endpoints A1, B1, C1 analyzed as the proportion of subjects whose performance improved or remained the same (difference ≥ 0) in unaided to aided comparisons.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=19 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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H. To Evaluate the Above Objectives on Individual Levels
PTA4 unaided to aided condition
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100 Percentage of participants (%)
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H. To Evaluate the Above Objectives on Individual Levels
All individual frequencies unaided to aided condition
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100 Percentage of participants (%)
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H. To Evaluate the Above Objectives on Individual Levels
Speech recognition scores unaided to aided condition
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100 Percentage of participants (%)
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SECONDARY outcome
Timeframe: Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1).Population: MHL/CHL - n=11 SSD - n=5
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. Hearing loss degradation for subjects with MHL/CHL is the difference in dB between masked (if not available, then unmasked) BC thresholds obtained at the study visit and at the visit when the Ponto 4(s) was fitted. For subjects with SSD, AC thresholds on the non-implanted ear were used for this calculation.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=16 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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I. To Assess the Degree of Inner Ear Hearing Loss Degradation on the Implanted Ear(s) (for SSD the Stimulated Ear).
MHL/CHL
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0.114 dB
Standard Deviation 5.761
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I. To Assess the Degree of Inner Ear Hearing Loss Degradation on the Implanted Ear(s) (for SSD the Stimulated Ear).
SSD
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1.75 dB
Standard Deviation 2.88
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SECONDARY outcome
Timeframe: fitting visit ≥6 weeks prior to study visit1\. 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1).Population: Air to bone gap (PTA4) at fitting and study visit across MHL/CHL subjects.
1\. The difference between masked (if not available unmasked) BC and AC thresholds, denoted 'air to bone gap', calculated for frequencies 500, 1000, 2000 and 4000 Hz from audiogram measured at the study visit and the fitting visit.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=14 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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K. To Asses if Patients' With CHL/MHL Air to Bone Gap (PTA4) Has Increased/Decreased on the Implanted Ear(s)
Fitting visit
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45.8 dB
Standard Deviation 13.6
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K. To Asses if Patients' With CHL/MHL Air to Bone Gap (PTA4) Has Increased/Decreased on the Implanted Ear(s)
Study visit
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50.2 dB
Standard Deviation 15.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1, Day 1Population: All participants included. Participants asked to rate their connectivity device(s) used, on a scale of 0.0 (very dissatisfied) to 10.0 (very satisfied).
1\. Questionnaire: Self-reported satisfaction ratings 0-10, for connectivity device(s) previously given to the test subject, where 0 is "very unsatisfied" and 10 is "very satisfied".
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=19 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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L. To Assess the Usage and Performance of Connectivity Device(s)
On App
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8.21 units on a scale
Standard Deviation 2.10
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L. To Assess the Usage and Performance of Connectivity Device(s)
Connect Clip
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6.90 units on a scale
Standard Deviation 2.30
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L. To Assess the Usage and Performance of Connectivity Device(s)
Remote Control
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8.00 units on a scale
Standard Deviation 2.35
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L. To Assess the Usage and Performance of Connectivity Device(s)
Edu Mic
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9.00 units on a scale
Standard Deviation 0.00
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OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1, Day 1Questionnaire: Self-reported usage hours per day during the month prior to the study visit across all subjects.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=19 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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F. To Assess the Usage Time With Ponto 4.
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12.6 average hours/day
Standard Deviation 5.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1, Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week)GHSI Questionnaire: Scores across all subjects, on a scale from 0 to 100, with a higher score indicating a better quality of life.
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=19 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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E. To Assess the Quality of Life of the Ponto 4
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65.4 units on a scale
Standard Deviation 11.7
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OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1,Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week)SSQ Questionnaire: Scores across all subjects, on a subjective scale from 0-10, where 0 is "the worst" and 10 is "the best"
Outcome measures
| Measure |
Ponto 4 Sound Processor Users
n=19 Participants
Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s).
Audiometry: 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.
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|---|---|
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D. To Assess the Subjective Experience of the Ponto 4
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6.28 units on a scale
Standard Deviation 1.91
|
Adverse Events
Ponto 4 Sound Processor Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place