DOI: https://doi.org/10.21203/rs.3.rs-1914136/v1
Background:
Population ageing is a global phenomenon. Hearing loss prevalence, indeed, increases with age. Hearing loss in elderly deteriorates hearing abilities and consequently cognition, sociality, sensitivity and the quality of life. Different studies reported that hearing aids have a positive effect on the cognitive outcome but most of them do not compare the performances before and after the hearing aids (HA) fitting. The primary aim of this study is to investigate the adherence to HA use in a group of elderly people one year after their first fitting. In particular, we want to analyze which factors influence the adherence. Subsequently, we evaluated the evolution of the different parameters analyzed after one year of HA use.
Methods:
86 elderly patients affected by moderate or moderate to severe hearing loss were consecutively recruited. They were evaluated during two assessments: one before (Pre) and one after one year of first HA experience (Post). Audiometric measures, questionnaires and a cognitive test were performed at each assessment. More details about study design and inclusion/exclusion criteria are reported in our previously published study protocol.
Results:
69.8% of the participants continued to use HA one year after the first fitting. At the comparisons USERS were younger than NON-USERS. Furthermore users have a statistically better unaided auditory threshold and basic cognitive status. No differences were found in speech audiometry, HHIE and Quality of life score.
39 patients completed Pre and Post evaluations. Significant improvements in speech audiometry and auditory threshold, HHIE, AQoL and IOI-HA score were observed. No difference was found in MOCA score.
Conclusions:
An high percentage of adherence to HA use has been observed in elderly with moderate or moderate to severe HL. The adherence to HA use is correlated with lower age, lower hearing loss degree, good basal cognitive capacities and better quality of life perception at first fitting. Use of hearing aids over time, leads to an improvement of the auditory performances, a reduction of the effect of the hearing impairment in everyday situations and absence of deterioration of the cognitive functions. Bilateral device users experience better performances and satisfaction than monolateral.
Trial registration: This research was retrospectively registered under no. NCT04333043 at ClinicalTrials.gov (http://www.clinicaltrials.gov/) on the 26 March 2020. This research has been registered with the Ethics Committee of the Area Vasta Emilia Nord under number 104, date of approval 17/07/2017.
Population ageing is a global phenomenon, affecting particularly developed countries. Different factors are contributing to increased life expectancy, including improvements in health care and medical technologies, social and economic development. The last estimate is that European mean age will increase by 4.5 years during the next 30 years. This transformation is impacting economy, society and especially the healthcare systems considering that a high number of older people suffer from physical or sensory functional deficits affecting mobility, communication, memory, vision, and hearing [1]. Hearing loss (HL) prevalence, indeed, increases with age [2] and according to WHO World report on hearing [3] the global prevalence of moderate or higher grades of HL rises from 12.7%at 60 years to over 58% at 90 years old. As a matter of fact, this demographic shift due to population ageing and population growth will influence the HL epidemiology [4].
The main cause of HL in older adults is presbycusis, which deteriorates hearing abilities (sound detection, localization and speech discrimination, especially in noisy situations) and consequently cognition, sociality, sensitivity and more generally the quality of life [5]. Moreover, it was shown that the association of HL with age-related cognitive decline has a negative impact on auditory skills and the execution of psychoacoustic tasks [6].
The most common strategy to correct presbycusis is sound amplification with hearing aids (HA). Different studies reported that these devices have a positive effect on the cognitive outcome [7–9] but most of them do not compare the performances before and after the HA fitting.
The Italian National Health System (NHS) funds partially or totally the cost of HA; to obtain the fund, the patient must be affected by at least a moderate HL in the best ear. Due to the raising number of elderly people the demand for hearing aids is expected to grow, with a subsequent economic impact on the NHS.
It is therefore essential to understand the real efficacy and use of hearing aids over time.
The primary aim of this study is to investigate the adherence to HA use in a group of elderly people one year after their first fitting. In particular, we want to analyze which factors among different domains like auditory outcomes, subjective perception of the hearing impairment, quality of life and the cognitive status influence the adherence.
The secondary aim is to determine the evolution of the different factors analyzed after one year of HA use.
This is an observational, prospective, monocentric study conducted at the outpatient service of the ENT Department of the “Guglielmo da Saliceto” Hospital in Piacenza, Italy.
This research was retrospectively registered under no. NCT04333043 at ClinicalTrials.gov (http://www.clinicaltrials.gov/) on the 26 March 2020 and it is registered with the Ethics Committee of the ‘Area Vasta’ Emilia-Nord under number 104 (date of approval 17/07/2017). This study adheres to CONSORT guidelines.
All subjects signed the Patient Informed Consent Form before the first assessment (Baseline, t0).
The main inclusion criteria are age older than 65 years, at least moderate HL in the best ear and use of unilateral or bilateral HA for the first time.
The study includes two assessments at our ENT Department: one before the first use of HA (Pre) and one after one year of HA experience (Post). Audiometric measures, questionnaires and a cognitive test were performed at each assessment.
More details about study design, instruments, timing of assessment and inclusion/exclusion criteria are reported in our previously published study protocol [10].
To implement the investigation of factors influencing the use of HA, subjects are classified in two groups. USER group is composed by patients who attended the one year follow up visit or those who reported HA use at telephonic interview. All patients who attended the follow up visit were HA user. NON-USER group is composed by subjects who did not attend the follow-up visit and reported the abandon of HA at the telephonic interview.
Telephonic interviews were performed for patients who were unable to attend the follow up visit, due to SARS-COVID19 pandemic or to health problems.
Different factors are analyzed during the medical appointments, including:
Monolateral or bilateral HA usage
Auditory performances: pure tone audiometry, speech audiometry, Italian version of Oldenburg Satz test (OLSA test) [11]
Cognitive functions: Montreal Cognitive Assessment (MOCA test) [12]
Quality of life: Assessment of Quality of Life (AQoL 8D) (with particular focus on the “Senses” subscale evaluating hearing, visual and energy) [13]
Daily life impairment: Hearing Handicap Inventory in the Elderly Screening test (HHIE) [14]
HA satisfaction: International Outcome Inventory for Hearing Aids (IOI-HA) [15] (only in the Post assessment)
In particular, we evaluated Pure Tone Average (PTA) in the pure tone audiometry and Speech Reception Threshold (SRT) in the speech audiometry. PTA is the average air-tonal threshold at 500, 1000, 2000, and 4000 Hz frequencies. Speech Reception Threshold (SRT) is defined as the level of speech corresponding to 50% of correct answers. PTA and SRT were evaluated in free-field unaided condition before the first fitting of the device and in free-field aided condition in the Post assessment.
To compare the distribution of different variables in the user and non-user groups we use t-tests for independent samples whenever the assumption of normality is not rejected (based on a Shapiro-Wilk test). If normality fails, we replace the t-test with Wilcoxon rank-sum test. The null hypothesis in this procedure is the equality of the two distributions (and not only their means) but reduces to the equality of the two means of the t-test in the case of normality. Similarly, when comparing pre and post evaluations, we use t-test for paired samples if normality is not rejected and its non-parametric equivalent (Wilcoxon signed rank test) when normality fails.
116 patients were consecutively recruited for the study but 30 of them, although they signed the Consent Form, did not show up for the first appointment.
Therefore the sample consists of 86 patients with an average age of 82.1 years (range 67–95; SD 6.9); 48 females and 38 males. All of them were affected by moderate to severe hearing loss with a mean unaided PTA of 72.2 dB (range 51.2–115 dB; SD. 12.6) and with a mean unaided SRT of 72.3 dB (range 45–110 dB; SD 21.1). On average, patients showed hearing difficulties in noisy environment with a mean OLSA score of 8.6 dB SNR (range from − 0.6 to 22.7; SD 5.4).
39 of the 86 patients attended Pre and Post evaluations and all of them were HA user. The remaining 47 completed only the first evaluation (Pre) and did not attend the follow-up visit; all of these were contacted for a telephonic interview: 21 were actually HA users, 6 were non-users of the device, 10 were dead and 10 did not answer to the interview.
No statistically significant difference was observed when comparing the mean age of the patients who completed (n = 39) and who did not complete (n = 47) the protocol evaluation schedule (80.8 vs 83.1 years).
USER group is formed by 60 subjects: 39 patients who attended the one year follow up visit and 21 who reported HA use at telephonic interview. 6 patients compose the NON USER group.
We analyzed the mean age, the presence of comorbidities, PTA, speech audiometry and questionnaires results in the two groups at first evaluation to better understand the potential impact of these factors in the usage.
A mild difference was found between the mean age of the two groups (80.7 years in USER group vs 86.0 years in NON-USERS; p-value 0.08) (Fig. 1)
88.3% (n = 53) of the USERS and 83.3% (n = 5) of the NON-USERS presented at least one comorbidity. Among these, 6 (10%) USERS and none of the NON-USER group were affected either by mild cognitive disorder, dementia or depression.
The mean number of the comorbidities per patient was 1.6 in USER group and 1.1 in NON-USER group.
At Pre evaluation, there is a statistically significant difference between the PTA distribution in the two groups (p-value 0.017) according to Wilcoxon rank-sum test: the mean PTA in the NON-USER group was 87.5 dB in NON-USER and 70.8 dB in USER group. The location shift of the Wilcoxon rank sum test found not statistically significant (p-value 0.12) when comparing the SRT of the two groups (median values 65 dB in USERS vs 70 dB in NON-USERS).
The differences between USERS and NON-USERS in the questionnaires are shown in Table 1. Differently from the comparisons of PTA and SRT test scores we use t-tests in these comparisons as normality is never rejected.
The mean HHIE score in the USER group was 0.14 points lower than in the NON-USER group (p-value 0.97), indicative of equal effects of hearing impairment on emotional and social adjustment in everyday life in the two groups. No statistically significant differences were found also in the two HHIE subscale (p-value 0.67 in the emotional subscale and p-value 0.48 in the social subscale).
No statistically significant difference (p-value 0.39) was found between the mean AQoL scores. On the other hand, analyzing the “Senses” subscale a mild difference was observed (8.2 point in USER vs 9.3 in NON-USER; p-value 0.08).
A weakly significant difference (p-value 0.059) was found in the MOCA score between the two groups suggesting a better cognitive status in the USERS.
|
USER |
NON USER |
∆ |
p-value (t-test) |
|
|---|---|---|---|---|
|
HHIE |
23.5 (sd 9.6) |
23.3 (sd 7.0) |
0.1 |
0.97 |
|
AQoL-8D |
78.6 (sd 19.3) |
85.5 (sd 11.6) |
6.9 |
0.39 |
|
MOCA |
19.0 (sd 5.02) |
15.0 (sd 3.22) |
4.0 |
0.059* |
Different domains were evaluated in the USER group to investigate the benefits of the one year of HA use in elderly. The same indicators were analyzed after dichotomizing the subjects in monolateral (n = 24) and bilateral (n = 36) HA users for verify the efficacy of the one or two device use.
Even though all the patients were affected by at least a moderate hearing loss in the best ear, some of them decided to use just one HA.
The PTA and SRT were evaluated in free-field unaided condition before the first fitting of the device and in free-field aided condition in the Post assessment in 38 patients. Comparison between unaided auditory results in Pre evaluation and aided results in Post evaluation was performed to investigate the audiometrical benefit of the HA use. We also verified that mean auditory threshold (PTA) and mean speech auditory performance (SRT) in unaided condition have not changed for the duration of the study.
The mean unaided PTA in Pre evaluation was 71.6 dB (71.9 dB in the bilateral and 73.6 dB in the monolateral users) whereas the mean aided PTA in Post assessment was 48.3 dB (48.4 dB in the bilateral and 48.3 dB in the monolateral users). The PTA difference was 23.3 dB (23.6 in bilateral and 25.3 dB in monolateral) (p-value < 0.001).
The median SRT was 65 dB in the Pre evaluation while it was 55 dB in the Post evaluation. In table 2 is reported the mean SRT and mean variation in patients using monolateral or bilateral HA at Pre and Post evaluation. The differences are statistically significant for both groups (p-values computed according to Wilcoxon signed rank test are 0.019 for the Mono group and < .001 for the Bil group (Wilcoxon rank sum tests in both cases).
Only 11 patients performed OLSA test in both Pre (unaided) and Post (aided) evaluations. The mean score at Pre was 8.4 dB SNR (St.Dev. 3.7; Range 1.5 to 13.8) and at Post it was 4.4 dB SNR (St.Dev. 4.3; Range − 1.3 to 12.2). Therefore the mean difference was 4.0 dB SNR (St. Dev. 5.5; range − 8.1 to 10.8). Table 2 shows the difference between monolateral and bilateral HA users at OLSA test. Despite the small sample size, the difference is statistically significant for the Mono group (t test, p-value 0.014); it is not in the bilateral group.
|
SRT Pre |
SRT Post |
SRT difference |
OLSA Pre |
OLSA Post |
OLSA difference |
|
|---|---|---|---|---|---|---|
|
HA Mono |
75.5 (sd 24.0; range 45–110 dB (n = 13) |
61.5 (sd 22.3; range 40–110 dB (n = 13) |
15.1 dB (p < 0.001***) |
11.0 dB SNR (n = 5) |
5.2 dB SNR (n = 5) |
5.8 dB SNR (range 2.5–10.8; sd 3.3) (p = 0.014) |
|
HA Bil |
70.4 (sd 21.5; range 45–110) dB (n = 25) |
50 (sd 8.3; range 35–65) dB (n = 26) |
20.6 dB (p 0.019**) |
6.2 dB SNR (n = 6) |
3.7 dB SNR (n = 6) |
2.5 dB SNR (range − 8.1- 9; sd 6.8) (p = 0.406) |
| Significance codes: 0 ‘***’ 0.001 ‘**’ 0.01 ‘*’ 0.05 ‘.’ 0.1 ‘ ’ 1 | ||||||
The scores of the questionnaires are shown in table 3.
A mild reduction of the cognitive performances (MOCA test) is observed in monolateral subgroup and in the whole USER group comparing Pre and Post evaluations; whereas there was no difference in the bilateral subgroup.
A worsening in quality of life (AQoL-8D) was seen in all the subjects and in both subgroups. On the contrary, the “Senses” subscale showed an improvement in the total and in the bilateral group (0.15 and 0.38 points) while it worsens in monolateral users (-0.31 points).
HHIE score showed a statistically significant difference between Pre and Post evaluation (p-value 0.0002). After dichotomizing in monolateral and bilateral use of the hearing aids, only the subjects who used two devices showed an improvement of the score whereas the monolateral users had a reduction of 1.54 points.
Bilateral users were more satisfied of the HA effects (IOI-HA) compared to monolateral users after one year.
|
MOCA (n = 35) |
AQoL-8D (n = 39) |
HHIE (n = 39) |
IOI-HA (n = 38) |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre |
Post |
∆ |
Pre |
Post |
∆ |
Pre |
Post |
∆ |
Post |
|
|
MONO |
19.7 (sd 4.5; range 13–28) |
17.8 (sd 6.2 Range 4–27) |
-1.9 (p= 0.182) |
77.2 (sd 19.7; range 51–111) |
88.5 (sd 18.3; range 64–129) |
-11.3 (p= 0.075) |
19.4 (sd 11.1 range 4–40) |
20.9 (sd 12.0 range 4–40) |
-1.5 (p= 0.692) |
24.9 (sd 4.8; range 16–34) |
|
BIL |
19.7 (sd 4.9 Range 9–26) |
19.7 (sd 4.9 Range 9–30) |
0 (p= 1) |
76.2 (sd 18.7; range 46–112) |
80.6 (sd 19.7; range 52–138) |
-4.4 (p= 0.087) |
24.1 (sd 9.0 range 6–40) |
13.2 (sd 10.4 range 0–40) |
10.8 (p < 0.001***) |
29.2 (sd 3.8; range 21–35) |
|
TOT |
18.6 (sd 4.7 Range 9–28) |
19.1 (sd 5.3 Range 4–30) |
-0.6 (p = 0.44) |
78.8 (sd 18.8; range 46–112) |
83.3 (sd 19.3 range 52–138) |
-6.7 (p = 0.012*) |
24.5 (sd 9.8 range 4–40) |
15.8 (sd 11.4 range 0–40) |
6.7 (p = 0.003**) |
27.9 (sd 4.2; range 16–35) |
| Significance codes: 0 ‘***’ 0.001 ‘**’ 0.01 ‘*’ 0.05 ‘.’ 0.1 ‘ ’ 1 | ||||||||||
From the evaluation of the item 1 of the IOI-HA questionnaire we observed that 3 patients used in average the HA 1–4 hours/day; 10 subjects 4–8 hour/day and 26 more than 8 hours/days. No significant differences in the mean number of comorbidities was shown between subjects that used HA less than 8 hours/day (n = 13; mean of comorbidities 1.5; sd 0.8) and subjects with an high HA daily use (> 8 hours/days) (n = 26; mean of comorbidities 1.5; sd 1.1).
The primary aim of this study was to describe older adults ‘adherence to hearing aids use in the first year after fitting.
69.8% (n = 60) of the 86 participants in the study continued to use one or two HA one years after the first fitting. Only 6 subjects were non-user (7%) while the remainder were dead or did not answer to the interview.
The observed percentage of non-use is considerably lower compared to data reported in the recent literatures. Kim et al showed that 19.5% of the subjects were no longer users of the hearing aids. The authors illustrated that non use correlated with listening difficulties in noise and with the uncomfortable devices [16]. Also, in a study of Solheim and colleagues is reported a percentage of non user equal to 15.5%. The authors reported that the issues most strongly associated with HA non-use were correlated to “no perceived need”, handling difficulties and not optimal sound quality whereas they did not found any correlation with cosmetic concerns [17].
The divergences between the studies are partly related to different samples, time of follow-up and methodological approaches used (e.g. survey, interviews or personal letter-form). The population recruited in our study in fact has moderate to severe average hearing loss with average levels higher than those reported in other studies. Therefore it seems reasonable to assume that it expresses a population with greater rehabilitation needs.
In addition, most of the literature is based on retrospective studies whereas our study is prospective. It is important to note that 10 patients did not answer to the telephonic interview and it is not possible to know if there are some HA user in this sample.
For better understanding which aspects are correlated with the use of the hearing aids in elderly, we analyzed different factors. We found that age, hearing threshold, cognitive status and quality of life perception influence the use of the hearing aids over time.
In particular we found that age at the first HA fitting is 6 years lower, on average, in user group compared to non users. Literatures do not agree regarding relationship between age and HA use. Humes reports absence of correlation between age and HA adhererence [18] whereas Kim et al., who evaluated the HA satisfaction, reported a correlation between lower age and higher HA satisfaction similar to our data [16]. These last authors described, in fact, a decrease of 0.3 point of HA satisfaction every one year of age increased.
It is well known that elderly people can present with many comorbidities [19] including difficulties in movements. This can result in frequent appointments miss after the initial fitting, fundamental for a proper HA assistance. In accordance with the literature, we found that both user and non-user subjects presented at least one comorbidity but these are not statistically associated with the adherence to devices use. Also 6 of the 86 subjects had disorders like mild cognitive impairment, dementia or depression that could correlate with less HAs use. In addition, the number of comorbidies was not correlated with the mean use of the HA. Probably, for these reasons our sample showed greater adherence to the device use. In contrast to our data, Solheim et al reported that the presence of at least one comorbidity is correlated with an average lower use of 3.3 h/day compared to participants who reported no issues: in particular subjects with health related problems used their hearing aids 3 hours less per day compared to healthy people [17].
In the present study, impact of the hearing loss in elderly subjects are correlated also with the unaided hearing threshold. In fact, the mean hearing threshold is lower in user compared to non-user recipients. Some studies report that subjects with identical audiograms had different perceived hearing difficulties [18] whereas others reported that there is a correlation between hearing loss degree and usage of hearing devices [17]. Both studies of Solheim and Humes reported that non user subjects had a better hearing threshold compared to user [17; 18]. On the contrary, here we found better hearing threshold in the user group. This difference is probably associated with sampling criteria: in fact, were recruited subjects with moderate to profound HL, whereas other studies include less severe HL. Also from the analysis of the auditory performances with HAs, we found a significant correlation between unaided and aided tonal audiometry and SRT. All subjects showed an improvement of the auditory threshold with their HAs both in quiet and in noise. It is possible that the audiological benefit, correlated with the HAs use, is a cause of the adherence to devices use over time.
We found that another factor that influence the HAs use is the cognitive status. Despite a lower score of all subjects compared to the general population, a weakly significant correlation between greater MOCA score and HA user status was apparent. We also found that there is not a deterioration of the cognitive capacities after one year of HA use as the MOCA score has not changed. Our data agree with the recent literatures. In the last years the scientific community has paid great attention to cognitive disorder. It is reported that untreated or not well treated hearing loss results not only in reduced speech audibility, but also in social isolation, depression and cause negative impact on cognitive function [18]. The Lancet Commission for dementia prevention, intervention, and care, described the risk and modifiable factors correlated to dementia. This commission identified that hearing loss is the largest potentially modifiable risk factor for this disease. Therefore by treating hearing loss it is possible to delay the onset of dementia by 1 year and decrease the global prevalence of dementia by 10% [20].
Comorbidities, alteration of the cognitive status, difficulties in speech perception, isolation are just some of the factors that affect elderly people with hearing loss. Consequently also the quality of life of these patients can be impaired. Literatures agree that elderly with hearing loss have a worse quality of life [21, 22]. In our study patients in the user group have a trend of better perceived quality of life than non users although differences are not statistically significant No differences were observed in the sense subscale of the questionnaire in user and non user subjects. It is important to note that the same user subjects, had a worsening quality of life perception one year after the first fitting but at the same time had a little improvement in the sense subscale. Tsimpida and coworkers showed that quality of life in elderly subjects that use HA was correlated with different factors, especially socioeconomic position and depressive state [23]. In our sample hearing aids improved the hearing status of subjects but other aspects have worsened according with ageing. Consequently we observed a reduction of the global score of the quality of life questionnaire and, on the contrary, the sense subscale (correlated with the hearing status) improves over time.
We did not find any statistical correlation between hearing aids use and HHIE score but a significant reduction of the score after one year of HA use was apparent (22.51 vs 15.79). In agreement with us, Uchida et al. found a reduction of the HHIE score from 30.8 points before to 18 points after the 6 months of HA use [24]. Also in a study of Zorzetto Carnil et al. is reported a correlation between use of hearing aids and HHIE score in elderly [21]. It is possible to conclude that the use of HA favored emotional and social adjustment in everyday life.
In accordance with this data, also IOI-HA, that illustrate the satisfaction of hearing aid users and the impact of the devices on life, showed scores similar to that of other studies.. Wu et al report a IOI-HA score of 24.97 point 3 months after use of hearing aid whereas in our study we found a similar score of 27.9 [25].
For better understanding the parameters that affect the HA use one year after the first fitting, we evaluated the advantages of binaural amplification. Bilateral users had higher HA benefit in speech audiometry in quiet but not in speech audiometry in noise compared to monolateral users. The greater improvement in OLSA test in the monolateral group must be related to a worse score at pre evaluation.
The bilateral use of HA after one year produces significant improvements in different questionnaires like in sense subscale of the AQoL, in HHIE and in IOI-HA questionnaires. On the contrary, both monolateral and bilateral users showed worsening total scores in AQoL questionnaire probably because of more general issues related to ageing.
No significant differences were found in MOCA score between bilateral and monolateral users but a trend of slight worsening in monolateral group and a stabilization in bilateral patients was apparent.
The improvement in IOI-HA score in bilateral users is not reported in the studies of Wu et al and Brännström et al that showed no differences in satisfaction of HA use in monolateral compared to bilateral patients [25, 26]. On the contrary, in agreement with our data, Arlinger et al reported that bilateral users had higher score, or rather higher satisfaction [27].
In general our study population shows good performances with bilateral HA. Cox et al also reported a preference of bilateral devices but there were not predictive factors concerning monolateral or bilateral preference [28]. Also, in a recent study Kim et al was reported a preference of bilateral HA use in elderly subjects [16].
In conclusion, this study underlines that the rate of HA adherence in a sample of older people suffering from moderate or moderate to severe HL is rather high. The use of HA is correlated with lower age at first fitting, lower hearing loss degree, good cognitive capacities and improvement in quality of life perception. On the contrary, the use of the devices are not correlated with the number of the comorbidities and the HHIE score.
Use of the hearing aids over time (1 year), leads to an improvement of the auditory performances, a reduction of the effect of the hearing impairment in everyday situations and absence of deterioration of the cognitive functions; on the contrary we found a slight reduction of the quality of life perception. In general, bilateral HA users showed better performances and better satisfaction compared to monolateral users.
The benefit in audiometric performance, absence of deterioration of the cognitive functions and improvement in quality of life and in hearing impairment perception, reveal that the HA in elderly subjects had positive impact.
A limitation of the study is a small number of the subjects that complete the protocol one year after the first fitting partly due to SARS-COVID19 pandemic.
AQoL: Assessment of Quality of Life; IOI-HA: International Outcome Inventory for Hearing Aids; HA: Hearing Aids; HHIE-S: Hearing Handicap Inventory in the Elderly Screening test; HL: Hearing Loss; MoCA: Montreal Cognitive Assessment; PTA: Pure Tone Audiometry; SRT: Speech Reception Threshold
Ethics approval and consent to participate
Each collaborating clinic has obtained the Ethics Committee of the Area Vasta Emilia Nord: (number 104; date of approval 17/07/2017) Approval for their participation in the study and has obtained formal local approval prior to enrolling their first subject. Subjects are enrolled into the clinical investigation only after signing the written Patient Informed Consent Form prior to the first assessment (baseline, t0). The study is conducted in accordance with the most recent version of the Declaration of Helsinki, the EN ISO 14155:2011 and any regional or national regulations, as appropriate. All the personal data will be anonymised, assigning a code to each patient, exclusive of the study, so that they no longer relate to identifiable people.
Consent to publish
Subjects are enrolled into the clinical investigation only after signing the written Patient Informed Consent Form prior to the first assessment (baseline, t0).
Availability of data and materials
All data generated or analysed during this study are included in this published article and its supplementary information files.
Competing interests
The authors declare that they have no competing interests.
Funding
This study is not sponsored and it has not received external funding.
Authors' contributions
DC, AL and SG made a substantial contribution to the conception and the design of the study. Authors SG and AS have drafted the work and author DC managed the clinical project. Author EF analyzed and interpreted the patient data and performed the statistical analysis. All authors (SG, AS, EF, AL and DC) read and approved the final manuscript.
Acknowledgements
We would like, in advance, to thank all participants who will take the time to undergo evaluations throughout the study.