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Abstract

Importance

Single sided deafness (SSD) results in difficulties for comprehension in noise and spatial localization. Ponto is a percutaneous bone anchored implant (BAI) proposed to improve the auditory benefit in noise.

Objective

The main objective was to evaluate the auditory benefit in noise Ponto system brings to patients suffering from SSD. In addition, the complications within the 6 months after Ponto implantation whatever the initial indication were evaluated.

Design

Retrospective and multicentric study.

Setting

Three different French tertiary referral centers.

Participants

Patients who underwent surgery between 2012 and July 2021 with a Ponto BAI.

Intervention

All patients with SSD underwent the speech in noise test, “Vocale Rapide dans le bruit” (VRB) in a condition with the sound signal from the front and the noise from 4 lateral loudspeakers. The test was performed in 2 conditions: aided and unaided. The Bern Benefit in Single-Sided Deafness (BBSS) Questionnaire and a subjective Spatial-Visual Analogic Scale (S-VAS) evaluated the patients’ perception of benefits.

Main Outcome Measures

VRB Speech Reception Threshold score, BBSS and S-VAS scores, complications within 6 months after surgery mostly skin complications, chronic pain, and loss of the BAI.

Results

Using the VRB, a gain of −1.55 dB signal-to-noise-ratio was found with the Ponto system. Moreover, the unaided VRB score was correlated with the unaided/aided difference and by that predicative of BAI treatment benefit. The BBSS showed mean scores between 1.45 and 3.47 for each question and the S-VAS mean score was 3.32. These results confirm a subjective benefit brought to patients especially as 74.3% were without cutaneous complications.

Conclusion

The Ponto BAI is a reliable implant and together with a Ponto sound processor it provides good auditory in noise results.

Relevance

The VRB is a useful test for predicting the post-operative results that could be expected after surgery.

Keywords

bone anchored implant single sided deafness VRB

Graphical abstract

Key Messages

There is a significant gain with the Ponto system in single sided deafness (SSD) of −1.55 dB SNR.

The French test “Vocal Rapid dans le Bruit” is a test that might predict the result of bone anchored implant in SSD situations.

The duration of use of the Ponto system is a factor that contributes to improve the benefit in SSD.

Introduction

Single sided deafness (SSD) is a unilateral severe to profound sensorineural hearing loss, with the contralateral ear presenting a normal hearing function or a slight impairment. Its prevalence in the population is estimated to be below 1%.^1,2 While hearing remains satisfactory in a quiet environment, the situation is different in a noisy setting, where communication is hindered, and the difficulty in spatial localization further adds to the burden.^3,4 As this type of hearing loss cannot be corrected by traditional hearing aids, 3 main strategies can be proposed to patients: contralateral routing of the signal through hearing aids (CROS), bone anchored hearing system (BAHS), or cochlear implant.^1,5
-9

Cochlear implantation is the only option that restores audition with neural stimulation on the disabled ear and thus restores the binaural cues.¹⁰ This option remains more expensive and requires a speech therapy which can be seen as a drawback for patients.¹¹ Moreover, this option is not suitable in cases such as vestibular Schwannoma¹² or cochlear ossification or destruction.

The CROS hearing aids do not create a true binaural solution as they transmit the signal from the non-hearing side to the good hearing one. These hearing aids are non-surgical and can be easily removed; however, they require wearing devices even on the good hearing side.

The goal of BAHS is to use transcranial bone conduction to transmit sound from the impaired ear to the contralateral normal-hearing ear. This setup allows the patient to perceive sound not only from the normal-hearing side but also from the impaired side. It aims to restore the transmission of high frequencies that are blocked by the head and also not perceived on the impaired side, thereby improving both spatial localization and speech discrimination in noisy environments.¹³

There are 2 types of Bone Anchored Implants: percutaneous implant such as Baha (Cochlear, Sydney, Australia) and the Ponto System (Oticon Medical, AB, Askim, Sweden), and transcutaneous bone conduction implants such as the Bonebridge (Med-El, Innsbruck, Austria), the Osia (Cochlear), the Baha attract (Cochlear), the Sentio (Oticon Medical, AB).

The transcutaneous implants are bigger because they include a receiver that transmits the signal through the skin using a wireless transfer power system that needs coils on the external as well as the internal part¹⁴ and the vibrating system differs in its technology depending on the brand. The surgical procedure requires most frequently a general anesthesia, even if not always necessary and is more complex with a cutaneous flap and a more extensive drilling especially for the bone conduction floating mass transducer of the Bonebridge.^15,16

The percutaneous implants, composed of a titanium screw and abutment, are much smaller. The surgery involves a minimally invasive procedure often under local anesthesia with a short duration.¹⁷ Moreover, the implant can easily be removed without causing permanent damage¹⁸ preserving the option of cochlear implantation at a later stage. But in contrast, there is a risk of skin complications.¹⁹

To assess the benefit of a binaural restoration provided by the Ponto implant rehabilitation in noisy conditions, the “Vocale Rapide dans le Bruit” (VRB) test, a widely used French speech-in-noise audiometry test, can be used.^20,21 This test helps identifying patients who experience hearing difficulties in noise despite normal tonal thresholds based on ISO 7029 norm.²¹ The VRB test is particularly advantageous due to its short duration and high reproducibility, making it a practical tool for routine hearing impairment assessments.²² This study is the first to evaluate the binaural hearing restoration using the Ponto system in SSD especially with a test specifically designed for French native speakers.

The aim of this study was to evaluate the auditory performance in noise of the Ponto system for single-sided deafness using the VRB test as well as to assess its side effects.

The Ponto system was selected due to the limited existing literature and to ensure a uniform patient group. The Osia or Bonebridge processors transmit the sound signal to the implant according to a completely different mechanism compared to the percutaneous Ponto system.

Materials and Methods

Patients

This was a retrospective and multicentric study of patients implanted with a Ponto BHX implant. Patients included in this study underwent surgery between 2012 and July 2021 in 3 different French tertiary referral centers. In France, the cost of Ponto System is fully covered by the national health insurance and the system was not provided to the patients specially for the study. All procedures performed in the study were in accordance with the ethical standards of the institution and with the 1964 Helsinki Declaration and its later amendments. The authorization from the research management was granted in compliance with the MR004 reference methodology with the authorization of the National ENT ethical committee under the IRB 2024-11-046-AB. This study was also registered on the Health Data Hub with the number F20220214110429.

The following data were collected from medical charts of all patients: sex, age, etiology of deafness, side of deafness, surgical procedure (linear incision, punch incision and drill, minimally invasive Ponto surgery, mono drill procedure), complications within 6 months after surgery [skin complications according to Holgers classification,²³ chronic pain or spontaneous loss or trauma to the bone anchored implant (BAI)].

Skin complications were assessed by the surgeon during post-operative visits using the Holgers classification: 0—no reaction; 1—redness with slight swelling; 2—redness, moistness, and moderate swelling; 3—granulation tissue; 4—signs of profound infection implying implant removal.

The benefit of hearing in noise was studied only among patients who had had a BAI for an SSD indication. The Ponto sound processors used by patients were Ponto 3, Ponto 3 Power, Ponto 3 Superpower, or Ponto 4. To evaluate the outcomes with the Ponto system among SSD patients, audiological tests and quality of life questionnaires which are described in the sections below were given and filled out during routine follow-ups between October 2021 and March 2022.

Audiometric Tests

All audiological assessments were performed in a double-walled soundproof room. All included patients with SSD underwent standard pure tone audiometry on the good hearing side with a TDH-39 headphone and an AC-40 audiometer. The average hearing threshold was calculated for air and bone conduction at 500, 1000, 2000, and 4000 Hz (according to BIAP recommendations²⁴). Speech audiometry with French Fournier’s disyllabic lists of words was also performed on the same ear to determine the 50% speech recognition threshold with a TDH-39 headphone and an AC-40 audiometer.

The VRB test was conducted with the Ponto sound processor and unaided (without wearing the sound processor) in a free-field setting.²⁰ The patient was positioned at the center of a circle surrounded by 5 loudspeakers (SIARE^© Acoustique, France): 1 directly in front (0° azimuth), and 2 on each side at 45° and 135° azimuth. During the test, 8 lists of sentences were presented at a fixed signal level of 65 dB, while a cocktail party noise (babble noise consisting of 2 male and 2 female speakers conversing in French and English) was gradually increased by increments of 3 dB after each sentence. The first sentence was played without masking noise, the second with a signal-to-noise ratio (SNR) of +18 dB, the third at +15 dB, and so on, decreasing stepwise until reaching −3 dB SNR. Each list contained 8 sentences, each including 3 keywords. The patient was asked to repeat each sentence heard. After recording the responses, the software calculated automatically the SNR associated with 50% correct keyword identification in each sentence (SNR-50, or Speech Reception Threshold in noise using the Spearman-Kärber equation).

As the VRB is a speech test in noise, the lower the Speech Reception Threshold (SRT), the better the result. Thus, efficient hearing rehabilitation provides a negative gain.

Quality of Life Questionnaire

To evaluate the benefit of the BAHS, the Bern Benefit in Single-Sided Deafness Questionnaire (BBSS)²⁵ and a Spatial Visual Analog Scale (S-VAS) were used.

The BBSS is a 10 questions’ visual analog scale, the answers were quoted between −5 and 5 points for each question by the patient himself in the presence of the examiner. The higher the score, the better the benefit. A score under 0 implies that the patient feels to have a negative result with the BAI, reaching −5 in the worst situation. In contrast, a positive score indicates a positive benefit with a maximum score of +5.

The S-VAS consisted of putting the following question to the patient: “Since you received your BAI, how do you evaluate your ability to perceive the localization of an incoming sound compared to when you didn’t have the BAI?” The result was quoted on a scale between −10 and 10. A perception of worsening was represented by a score under 0 with a maximum negative benefit of −10 points, whereas an improvement would be above 0 with a maximum positive benefit of +10 points.

Statistical Analysis

All statistical analysis were performed using R-Studio software 4.2.0 version (POSIT, Vienna, Austria). Qualitative variables were described by their number and percentage. Quantitative variables were described by the mean and standard deviation (SD).

Considering the VRB test, the conditions for applying a parametric test were firstly evaluated with a Shapiro-Wilk test. Then it was decided to use either a Student’s t-test in case of a normal sample distribution, or if not, a Wilcoxon test.

The improvement of the SRT score obtained while the Ponto Processor was activated compared to when the patient was not aided by the Ponto was evaluated using the Pearson correlation test.

Considering the BBSS and the S-VAS, the mean values were calculated, and a one-sample t-test evaluated the existence of a real difference with the 0 score.

Differences were considered 2-sided statistically significant at P < .05.

Results

Auditory Performance in Noise of SSD

Out of 280 patients who had had a BAI, 39 patients were implanted because of SSD. Among them, 2 patients were excluded because they did not have the VRB test. Finally, only 35 patients had representative data for the purpose of the study.

Patient demographics and duration of Ponto Processor use by the patients included are shown in Tables 1 and 2. The mean period of use of the Ponto Processor before the hearing test was 39.4 months.

Table 1.

Study Population.

Sex
Male	13
Female	22
Side implanted
Right	17
Left	17
Unknown	1
Etiology
Postoperative	11
Vestibular Schwannoma	5
Sudden hearing loss	4
Congenital malformation	4
Meniere disease	2
Meningitis	2
Cholesteatoma	1
Posterior fossa meningioma	1
Otosclerosis	1
Paraganglioma	1
Inner ear trauma	1
Mumps	1
Unknown	1
Ponto sound processor
Ponto 4	23
Ponto 3 Superpower	5
Ponto 3	3
Unknown	4
Mean age [min-max]	54.0 years (SD = 16.0) [19-79]
Mean time using a Ponto device [min-max]	39.4 months [6-161]
Audiometric mean threshold on normal hearing ear
Air conduction	25.0 dB (SD = 13.4)
Bone conduction	20.7 dB (SD = 11.4)
Speech audiometry	31.5 dB (SD = 16.3)

Abbreviations: dB, decibel; SD, standard deviation.

Table 2.

Delay Between Processor Activation and VRB Evaluation.

Patient	Age of deafness	Delay after processor activation (months)	Reduction of gain with Ponto processor
1	60	6	−8.5
2	55	33	−1
3	41	15	−1
4	10	20	0.25
5	51	13	2
6	78	13	−3
7	50	16	−0.25
8	49	9	−1.5
9	76	14	−3.7
10	66	21	1.2
11	69	12	−0.75
12	26	6	1
13	73	16	−0.95
14	5	67	−2.5
15	13	84	0
16	21	32	−4.75
17	62	108	−4.75
18	10	6	−3.25
19	41	57	−0.5
20	37	145	−6.25
21	40	161	1.5
22	8	130	−1.25
23	0	15	−2
24	71	77	−3.75
25	0	66	−3.2
26	61	6	−7.5
27	Unknown	6	1
28	67	6	−0.5
29	44	10	−0.5
30	9	8	−1.5
31	0	75	−3.25
32	41	8	−2
33	7	21	−2.5
34	28	14	0.25
35	62	84	0

Abbreviation: VRB, Vocale Rapide dans le bruit.

SRT in noise measured with the VRB test was +4.26 dB SNR loss, IC 95 = [−1.46; +9.98] in unaided condition and at +2.72 dB SNR loss, IC 95 = [−2.54; +7.98] in aided condition. The mean gain with the BAHS was −1.55 dB SNR loss, IC 95 = [−6.03; +2.93] (P < .001) (Figure 1).

Figure 1.

Variation VRB aided with Ponto processor and unaided. VRB, Vocale Rapide dans le bruit.

We performed a secondary subgroup analysis studying the results of the patients using the Ponto system for less than 2 years and for over 2 years. Those results are presented in Table 3 and showed a greater reduction of the mean gain of −0.75 dB SNR among patients using the Ponto system for more than 2 years.

Table 3.

Subgroup Analysis Considering Duration of Use of Ponto System.

	Over 2 years		Under 2 years
Number of patients	13		22
Mean delay of use (months)	86.1		12.5
Mean SRT unaided (dB SNR)	+4.52		+5.05
Mean SRT aided (dB SNR)	+2.24		+3.52
		P-value		P-value
Reduction of gain	−2.28	.002	−1.53	.005

Abbreviations: dB, decibel; SNR, signal-to-noise-ratio.

A correlation test between the unaided situation and the gain obtained with the sound processor was evaluated. The gain obtained was calculated from the difference of aided and unaided SRT. Using the Pearson test, there is a statistically significant correlation with R = −.49 (P = .003) (Figure 2) indicating a moderate to strong correlation between an unaided situation and the gain obtained with the Ponto system.

Figure 2.

Correlation between without Ponto and difference.

Quality of Life Questionnaires in SSD With BAI

All the mean values of the questionnaires were significantly above 0, showing that patients found a subjective benefit using the Ponto Processor in SSD conditions (Table 4).

Table 4.

Quality of Life Questionnaires Results.

Questionnaires	Mean value (SD)	IC 95	P-value (one-sample test)
BBSS
Q1	3.46 (1.83)	[−0.1; 5.0]	<.001
Q2	3.38 (1.60)	[0.2; 5.0]	<.001
Q3	3.31 (1.75)	[−0.1; 5.0]	<.001
Q4	2.47 (2.13)	[−1.7; 5.0]	<.001
Q5	1.45 (2.48)	[−3.4; 5.0]	.001
Q6	3.03 (1.97)	[−0.8; 5.0]	<.001
Q7	1.47 (2.46)	[−3.35; 5.0]	.001
Q8	2.65 (2.07)	[−1.4; 5.0]	<.001
Q9	2.17 (2.53)	[−2.8; 5.0]	<.001
Q10	3.47 (1.39)	[0.7; 5.0]	<.001
S-VAS	3.32 (3.81)	[−4.1; 10]	<.001

Abbreviation: SD, standard deviation.

Evaluation of Complications After BAI

The complications from the 280 analyzed records of implanted patients in the 3 hearing centers, either for conductive hearing loss or single-sided sensorineural deafness, were collected. The characteristics of the patients are given in Table 5 and all the complications are in Table 6. All patients with a Holger 1 or 2 fully recovered within 6 months after the surgery.

Table 5.

BAI—Population Characteristics.

Number of patients	280
Age	55.0 years old (SD = 17.7)
Surgical procedure
MIPS (total)	148 (52.9%)
Center 1	52
Center 2	81
Center 3	64
MONO (total)	9 (3.2%)
Center 1	2
Center 2	7
Center 3	0
Punch and drill (total)	72 (25.7%)
Center 1	0
Center 2	66
Center 3	6
Linear incision (total)	12 (4.3%)
Center 1	0
Center 2	8
Center 3	4
Unknown	39 (13.9%)
Center 1	0
Center 2	0
Center 3	39
Abutment length
12 mm	40 (14.3%)
Center 1	0
Center 2	27
Center 3	13
9 mm	153 (54.7%)
Center 1	49
Center 2	95
Center 3	9
6 mm	39 (13.9%)
Center 1	8
Center 2	29
Center 3	2
Unknown	48 (17.1%)
Center 1	0
Center 2	11
Center 3	37

Abbreviations: BAI, bone anchored implant; MIPS, Minimally Invasive Ponto Surgery; MONO, mono drill procedure.

Table 6.

BAI Complications Within 6 Months After Surgery.

Cutaneous complications
Holger 0 (total)	208 (74.3%)
Center 1	33
Center 2	125
Center 3	50
Holger 1 (total)	21 (7.5%)
Center 1	6
Center 2	9
Center 3	6
Holger 2 (total)	28 (10.0%)
Center 1	6
Center 2	18
Center 3	4
Holger 3 (total)	12 (4.3%)
Center 1	8
Center 2	1
Center 3	3
Holger 4 (total)	11 (3.9%)
Center 1	1
Center 2	9
Center 3	1
Chronic pain (total)	12 (4.2%)
Center 1	12
Center 2	0
Center 3	0
Bone infection (total)	0 (0%)
Spontaneous implant fall (total)	24 (8.6%)
Center 1	4
Center 2	12
Center 3	8
Mean duration before implant fall	46.6 days
BAI removal (total)	3 (1.0%)
Center 1	2
Center 2	0
Center 3	1
Other complication (total)	0 (0%)

Abbreviation: BAI, bone anchored implant.

Discussion

This retrospective and multicentric study demonstrated a significant benefit of the Ponto hearing aid in improving speech recognition in noise for patients with SSD, with a reduction of 1.55 dB SNR in the SRT in noise, as measured by the VRB test.

The results from the present study are not totally in line with what has been previously reported for similar solutions. Most study found a benefit of the BAHS on the SNR when the noise is sent on the good hearing ear and the sound signal coming from either the front or the deaf side.^7,26,27 Yuen et al⁷ using a configuration with the sound signal from the front and the noise from behind the subject has shown a worse result with an increase of the score of +1.6 dB SNR.

Comparing the results obtained with an active and transcutaneous implant (ie, Bonebridge), the speech audiometry in noise with the Matrix test showed an SRT of −4.2 dB SNR and −5.4 dB SNR with the Samba and Samba 2 sound processors, respectively, compared to −3.5 dB SNR when unaided in Wimmer et al’s study.²⁸ The benefit with the Samba was not significant contrary to the Samba 2. In a more recent study, Kim et al found no significant improvement of the SNR when the sound does not come from the implanted side.²⁷ It is important to note that some patients had been using the processor for longer periods than others in our study, as the first SSD case was implanted in 2008 and evaluated in 2021. The mean period of use of the Ponto system in our study was quite long, 39.4 months compared to 3 months in Kim et al’s²⁶ and Yuen et al’s study.⁷

The BAHS do not restore true binaural hearing, as they reroute sound from the deaf side to the hearing ear. However, 4 mechanisms may explain the observed SNR improvement. First, BAHS may transmit some acoustic energy to the impaired ear, which despite not bringing any comprehension could aid in sound localization and tinnitus reduction.^1,29 Second, Kim et al reported SNR improvement when sound is directed to the implanted ear, most probably due to transmission of high-frequency signals otherwise blocked by the head shadow effect (due to their smaller wavelengths than the head size).^26,27 This mechanism re-establishes access to these frequencies via the hearing ear, although we did not examine this effect here. Notably Kim et al found no improvement for frontal sound sources, unlike our findings. Third, BAHS enhances skull-conducted sound transmission by reducing impedance mismatch between air and bone. The implant radiates mechanical energy omnidirectionally through the skull taking different routes (the vertex, the forehead, the back of the head), possibly creating artificial timing differences and a noise averaging that can help in spatial localization and the discrimination of the signal out of the noisy environment.²⁹ Fourth, the signal perceived by the implant is transmitted to the hearing ear which thus perceives a higher intensity of the signal because not only the signal comes to it naturally but also through bone conduction.

The long period of use of the Ponto system seems to be one factor explaining our results not found in other studies. This was demonstrated in our subgroup analysis (Table 3) with patients using the Ponto for more than 2 years having a greater reduction of gain. We can bring forward 2 possible explanations: firstly, we may expect a greater osteointegration of the implant in our study providing better conduction of the sound signal according to the mechanism described previously; secondly, there may be a role played by brain plasticity with the Ponto system.

This is the first study assessing BAI performance using the VRB test, a quick, reliable, and easy-to-administer tool. Its short duration helps to maintain patients concentrated throughout the test.²⁰ We chose to conduct the VRB test with the speech signal coming from the front and masking noise from 4 lateral loudspeakers, as this setup closely resembles real-life listening conditions. In everyday conversations, individuals typically focus on the speaker in front of them rather than on sounds coming from the sides.

The correlation analysis (R = −0.49) suggests a moderate to high correlation between the unaided situation compared to the gain obtained with the Ponto system. This is the first time that a test is able to predict the benefit of a BAI rehabilitation. The practical implication of this finding is that the higher the VRB results in SSD, the better the outcome expected with a BAI.

The BBSS and S-VAS scale values were statistically significantly higher than 0, indicating that patients perceived improved hearing benefits with the Ponto sound processor. This subjective improvement has been well-documented, particularly in SSD patients using similar solutions.^6,8,13,26,30 Kompis et al, who studied the BBSS with Baha prostheses, reported a total score of 25.1 points, while our study found a slightly higher mean score of 26.9 points.²⁵ However, as there was no direct comparison between the 2 systems, it is difficult to conclude that Ponto provides a superior outcome.

Regarding complications, the majority of reported undesirable events were minor cutaneous issues. All cases classified as under Holgers 3 resolved spontaneously, suggesting that the implant is safe, with fewer than 10% of patients experiencing significant complications. Our results appear more favorable than those of Teunissen et al, whose larger cohort had a Holgers score of 0 in fewer than 50% of cases, as they examined both Ponto and Baha implants.¹⁸ Kanzara et al reported Holgers 0 in 89% of cases and Holgers 1 in 7%.¹⁹ Finally, Lagerkvist’s meta-analysis estimated skin complication rates to be between 5 and 15%, depending on the study.²⁹

Among our 280 patients, only 3 required implant removal (<1%). In addition, 24 patients experienced spontaneous extrusion of the titanium pillar within 3 months due to a lack of osteointegration. Overall, complications with Ponto were very scarce, with 75% of patients experiencing no complications at all. These findings support the conclusion that the Ponto surgical procedure is generally well tolerated.

Conclusion

Our study has shown good hearing in noise results obtained with Ponto BAI, in patients with SSD. This result seems associated with the fact that the period of use of the Ponto system in our patients was quite long. The SRT performed with the VRB in unaided condition seems to be predictable of the favorable results which could be obtained with a Ponto BAI implantation. The evaluation of SSD patients using the VRB test should be taken into account as a valuable criterion when surgery for BAI is considered.

In conclusion, the BAI, apart from being well tolerated, gives good results while the incidence of severe complications remains low.

Footnotes

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: There is a conflict of interest with Oticon Medical who has given a grant to the Institution for the project.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Oticon Medical.

Ethical Approval and Informed Consent

The authorization from the research management was granted in compliance with the MR004 reference methodology with the authorization of the National ethical committee under the IRB 2024-11-046-AB. This study was also registered on the Health Data Hub with the number F20220214110429.

ORCID iDs

Ashley Baguant

Philippine Toulemonde

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Evaluation of the Auditory Performance in Noise of Bone-Anchored Hearing System in Patients With Single Side Sensorineural Deafness

Abstract

Importance

Objective

Design

Setting

Participants

Intervention

Main Outcome Measures

Results

Conclusion

Relevance

Keywords

Graphical abstract

Key Messages

Introduction

Materials and Methods

Patients

Audiometric Tests

Quality of Life Questionnaire

Statistical Analysis

Results

Auditory Performance in Noise of SSD

Quality of Life Questionnaires in SSD With BAI

Evaluation of Complications After BAI

Discussion

Conclusion

Footnotes

Declaration of Conflicting Interests

Funding

Ethical Approval and Informed Consent

ORCID iDs

References