Influence of tinnitus annoyance on hearing-related quality of life in cochlear implant recipients

doi:10.21203/rs.3.rs-1521511/v1

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Influence of tinnitus annoyance on hearing-related quality of life in cochlear implant recipients

https://doi.org/10.21203/rs.3.rs-1521511/v1

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Among cochlear implant (CI) recipients, there is no consensus on the impact of tinnitus on hearing-related quality of life (QoL). The aim of this study was to assess the relationship between hearing-related QoL measured by the Speech Spatial and Qualities of Hearing questionnaire (SSQ12) and tinnitus annoyance or perceived change in tinnitus annoyance after cochlear implantation. The study sample consisted of 2322 implanted adults across France, Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom. Information relating to QoL, measured using the SSQ12, tinnitus annoyance and change in tinnitus annoyance, assessed using single-item questions, were collected one or more years post-implantation. The relationship between SSQ12 total score and tinnitus annoyance or change in tinnitus annoyance was analysed using linear models adjusted for age and unilateral versus bilateral implants. Tukey pairwise tests were used to compare tinnitus levels. Tinnitus prevalence was 33.9% post-implantation. This prevalence varied significantly with age. Recipients with tinnitus had a significantly lower SSQ12 score than recipients without tinnitus. The SSQ score varied significantly with tinnitus annoyance, age and unilateral versus bilateral implants. Overall, cochlear implant recipients who experienced less bothersome tinnitus showed better subjective hearing-related QoL. Healthcare professionals should be aware of the need to prioritise tinnitus management for CI recipients to optimize the benefit of CI.

cochlear implant

tinnitus

hearing-related quality of life

speech spatial qualities of hearing scale

age effect

Tinnitus is the perception of sound in the ears or in the head without an external stimulus ¹. It is reported in 10 to 30% of the general adult population, and the prevalence increases with age ^2,3. Tinnitus does not only vary in terms of sound perception and location but also in terms of distress. Some people are not bothered by tinnitus at all, whereas others experience it as bothersome and debilitating. Up to 3% of the general population experience severe and bothersome tinnitus resulting in a substantial reduction in their quality of life ^2,4.

Hearing impairment is the most common risk factor associated with tinnitus ^5,6. People with severe to profound hearing loss can get hearing benefit from a cochlear implant (CI) when hearing aids no longer provide a sufficient level of speech understanding in everyday situations. Amongst CI candidates, pre-implant tinnitus prevalence ranges from 52–86% ^7–9. The cochlear implant primarily aims to partially restore hearing by providing electrical stimulation to the auditory nerve. Tinnitus reduction can be experienced as a beneficial secondary effect of cochlear implantation ^7,8,10−12. While some studies showed that tinnitus loudness, distress or annoyance can be reduced or suppressed after cochlear implantation, others reported that tinnitus can also be worsened in up to 10% of CI recipients, or induced in up to 4% of patients receiving a CI ^8,9. As the prevalence of tinnitus is relatively high in CI candidates and the effect of cochlear implantation on tinnitus distress seems to vary widely between patients, it is of clinical importance to further investigate the impact of tinnitus on CI recipients and how it might influence hearing performance with a CI.

There is no consensus about the influence of tinnitus on hearing performance. Some previous studies showed that tinnitus may interfere with speech perception and reduce hearing performance. Huang et al. compared speech perception between subjects with normal hearing and tinnitus and a control with normal hearing and no tinnitus ¹³. The subjects with tinnitus performed significantly worse than subjects without tinnitus. Mertens et al. found that unilateral tinnitus in a single-sided deaf ear reduced speech reception in the non-tinnitus ear ¹⁴. In contrast, Zeng et al. concluded from their data that tinnitus does not interfere with speech perception and perception of external sounds ¹⁵. Therefore, some uncertainties remain about the relationship between tinnitus and hearing performances.

Hearing-related quality of life (QoL) has become a standard outcome measure to quantify the hearing impairment and its associated deficits. Using patient-reported outcome measures, several studies found a negative correlation between tinnitus distress and hearing-related QoL in adult CI recipients, meaning that an increase in perceived tinnitus distress correlated with a decrease in hearing-related QoL ^9,16−18. Two studies showed that pre-operative tinnitus was associated with poorer hearing-related QoL outcomes post-implantation ^19,20. In a cohort of 210 adult CI recipients, Opperman et al. showed that both pre- and post-implantation tinnitus were predictive of poorer hearing-related QoL ¹⁸.

The association between tinnitus and hearing-related QoL in CI recipients remains unclear due to a lack of a large-scale study. The availability of hearing-related QoL in a large cohort of CI recipients, as in this report, presents an opportunity to investigate this association. In addition, identifying the relationship between tinnitus and hearing-related QoL might be clinically useful to understand the heterogeneity in hearing outcomes in CI recipients and better manage patient’s expectations. In this cross-sectional study, we aimed to assess the relationship between hearing-related QoL measured by the 12-item Speech, Spatial and Qualities (SSQ12) questionnaire, the level of tinnitus annoyance measured with a multiple choice question, and the perceived change in the level of tinnitus annoyance produced by cochlear implantation.

Study population

Data from subjects implanted with a Nucleus® CI512, CI522 and CI532 cochlear implants (Cochlear Limited, Macquarie University, NSW, Australia) were extracted from a post-market patient survey. This survey was designed to capture data on self-reported hearing performance and potential side-effects in cochlear implant users. Subjects were adults aged ≥ 18 years old at time of implantation with at least 1 year of experience using the device. Subjects were grouped by whole years of follow-up.

Data collection

The survey was provided digitally through a web-based survey platform, designed by Cochlear Ltd. Registered users of the Nucleus devices who subscribed to a mailing list were invited by email to participate in the voluntary survey between December 2019 and January 2020. Data were collected across seven European countries: France, Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom. All materials were provided in the local language of the participant. All participants consented to share their data with Cochlear, and to complete the survey. The data were extracted from the web-based survey platform and anonymized.

Survey

The Speech, Spatial, and Qualities of Hearing scale (SSQ) measures hearing-related QoL ²¹. For the purposes of the survey, the short form of the SSQ, the SSQ12, was used ²². It consists of twelve items that cover speech understanding, spatial hearing, and other qualities of sound. Each item is scored using a visual analogue scale ranging from 0 (not at all) to 10 (excellent). The items are then averaged to yield an overall SSQ total score.

Next in the survey, tinnitus presence was assessed using a single-item question. Subjects were first asked to report, at the time of the assessment, if they had tinnitus when the CI was active. If they reported tinnitus, they were asked to complete two single-item questions about how bothersome the tinnitus was perceived and how tinnitus changed since implantation. Possible self-reported tinnitus annoyance levels were not at all bothersome; slightly bothersome; quite a bit bothersome; moderately bothersome or extremely bothersome. For those reporting tinnitus, changes in tinnitus annoyance since implantation were assessed using seven different categories: much less bothersome; a little less bothersome; no change; a little more bothersome; much more bothersome; “I don’t recall the condition before surgery” and “I did not experience this condition before surgery”.

Demographics such as age, gender, time period with implant and unilateral versus bilateral implantation were collected from device registration. There were additional questions in the survey about other potential side effects of cochlear implantation (e.g., dizziness) and magnetic resonance imaging (MRI).

Ethical considerations

The ethics committee of Medizinische Hochschule Hannover (MHH) confirmed on May 2018 that the Medical Research Involving Human Subjects Act did not apply to the study and therefore an ethical waiver was obtained under the number 7896_MPG_23b_K_2018 and no official ethical approval was required. This study was performed according to the declaration of Helsinki. The subjects provided their informed consent to participate in the survey and to use their data after anonymization, which complies with the General Data Protection Regulation (GDPR).

Statistical analysis

Data analysis was performed using R version 4.1.2 and R Studio version 1.3.1073 (®R Studio). Any normally distributed data were presented as mean and standard deviation (SD). Where data were not normally distributed, data were reported as median and interquartile range (IQR). The distribution of variables was assessed using normal quantile plots.

Fisher’s exact or chi-squared tests were used to determine whether the tinnitus prevalence, differed between time with implant (1 year, 2 years and 3 years or more), age groups and between unilateral and bilateral implantation. Jonckheere-Terpstra tests (nonparametric one-way analysis of variance [ANOVA] for ordered alternatives) were used to determine whether the SSQ12 scores increased or decreased significantly between the ordinal tinnitus annoyance categories and change categories.

Linear regression models were developed to assess the association between tinnitus characteristics (self-reported tinnitus absence or presence, self-reported tinnitus annoyance, self-reported tinnitus annoyance change) and the SSQ12 scores. The usual regression assumptions were checked using a normal quantile plot of the residuals and plots of the residuals versus fitted values. Models were constructed with and without an interaction for time with implant and adjusted for age and unilateral versus bilateral implants as covariate factors. ANOVA tests were used to compare nested regression models to determine the significance of adding predictors. Relative importance of predictors was assessed using the Lindeman, Merenda and Gold’s (LMG) method available in the relaimpo R package ²³. Tukey pairwise tests were used to determine which pairs of tinnitus characteristics differed in SSQ12 scores. A p-value lower than 0.05 was considered statistically significant.

Study population characteristics

A total of 7387 CI recipients were invited to participate, of which 2322 consented. Table 1 summarizes the study population characteristics. The mean age of the cohort was 57.9 ± 15.7 years, with range 18 to 95 years. Fifty percent were female and 69.4% were unilaterally implanted.

Table 1. Characteristics of study population.

Characteristics

Age

Mean (SD)

Range

57.9 (15.7)

18-95

Gender, n (%)

Male

Female

Missing

1151 (49.6%)

1161 (50.0%)

10 (0.4%)

Implantation, n (%)

Unilateral

Left

Right

Unknown side

Bilateral

Missing

1612 (69.4%)

484 (20.8%)

498 (21.5%)

630 (27.1%)

695 (30.0%)

15 (0.6%)

Time with implant, n (%)

1 year

2 years

3 years or more

429 (18.5%)

522 (22.5%)

1371 (59.0%)

Tinnitus profile

Table 2 summarizes tinnitus characteristics. The presence of tinnitus was reported by 33.9% (787/2322) of responders and proportions were similar by time with implant (chi-squared test, p = 0.434, Table 3). A larger proportion of unilateral experienced tinnitus versus bilateral implants (35.5% vs 30.5%, p = 0.023, chi-squared test, Table 2) and the proportion of those with tinnitus differed between age groups (chi-squared test, p = 0.034, Table 4). Of those reporting tinnitus postoperatively, 11.1% (87/787) rated their tinnitus as not at all bothersome, 59.7% (470/787) considered it slightly or quite a bit bothersome, and 29.2% (230/787) qualified it as moderate to extremely bothersome (Table 2). Among those reporting tinnitus change postoperatively, 44.0% (346/787) of subjects reported a decrease in bothersome tinnitus since implantation and 18.0% (142/787) indicated that tinnitus had become a little or much more bothersome since implantation. No change in tinnitus annoyance since implantation was reported by 25.9% (204/787, Table 2) and 12.0% could not recall experiencing or having tinnitus before implantation.

Figure 1 shows the percentage of each tinnitus annoyance level within perceived change in tinnitus annoyance. A higher proportion of participants with much more post-implantation tinnitus also have more bothersome tinnitus compared to those with less post-implantation tinnitus (Fisher’s exact test, p < 0.001).

Table 2

Number (%) of subjects reporting tinnitus characteristics by unilateral versus bilateral implants.
	All (n = 2322)	Unilateral (n = 1612)	Bilateral (n = 695)	Missing (n = 15)	p-value
No tinnitus	1535 (66.1%)	1040 (64.5%)	483 (69.5%)	12 (80.0%)	0.023
Tinnitus	787 (33.9%)	572 (35.5%)	212 (30.5%)	3 (20.0%)
Tinnitus annoyance (n = 787)					0.463
Not at all bothersome	87 (11.1%)	65 (11.4%)	22 (10.4%)	0 (0.0%)
Slightly bothersome	241 (30.6%)	178 (31.1%)	62 (29.2%)	1 (6.6%)
Quite a bit bothersome	229 (29.1%)	167 (29.2%)	62 (29.2%)	0 (0.0%)
Moderately bothersome	167 (21.2%)	123 (21.5%)	43 (20.3%)	1 (6.6%)
Extremely bothersome	63 (8.0%)	39 (6.8%)	23 (10.8%)	1 (6.6%)
Tinnitus annoyance change (n = 787)					0.068
Much less bothersome	153 (19.4%)	110 (19.2%)	42 (19.8%)	1 (33.3%)
A little less bothersome	193 (24.5%)	144 (25.2%)	48 (22.6%)	1 (33.3%)
No change	204 (25.9%)	148 (25.9%)	56 (26.4%)	0 (0.0%)
A little more bothersome	72 (9.2%)	60 (10.5%)	11 (5.2%)	1 (33.3%)
Much more bothersome	71 (9.0%)	52 (9.1%)	19 (9.0%)	0 (0.0%)
Don’t recall the condition before surgery	33 (4.2%)	19 (3.3%)	14 (6.6%)	0 (0.0%)
Did not experience this condition before surgery	61 (7.8%)	39 (6.8%)	22 (10.4%)	0 (0.0%)
P-values are from chi-squared tests comparing unilateral and bilateral (i.e. missing category excluded). Bold indicates statistically significant p < 0.05.

Table 3

Number (%) of subjects reporting tinnitus relative to implant experience.
	1 year (n = 429)	2 years (n = 522)	3 or more years (n = 1371)	p-value
No tinnitus	295 (69%)	341 (65%)	899 (66%)	0.434
Tinnitus	134 (31%)	181 (35%)	472 (34%)
P-value is from a chi-squared test.

Table 4

Number (%) of subjects reporting tinnitus by age group.
	18–34 (n = 222)	35–44 (n = 214)	45–54 (n = 415)	55–64 (n = 596)	65–74 (n = 549)	75–95 (n = 324)	Missing (n = 2)	p-value
No tinnitus	162 (73.0%)	143 (66.8%)	273 (65.7%)	366 (61.4%)	367 (66.8%)	224 (69.1%)	0 (0%)	0.034
Tinnitus	60 (27.0%)	71 (33.2%)	142 (34.2%)	230 (38.6%)	182 (33.2%)	100 (30.9%)	2 (100%)
P-value is from a chi-squared test excluding the missing category. Bold indicates statistically significant p < 0.05.

Table 5

Multiple regression models of the SSQ12 total scores.
Coefficient	Parameter estimate	Standard error	t value	p-value	R²
Model 0: age and unilateral versus bilateral implants					3.4%
Intercept	5.60	0.18	31.14	< 0.001
Age (years)	-0.02	0.01	-5.40	< 0.001
Bilateral CI (versus unilateral CI)	0.56	0.10	5.77	< 0.001
Model 1: tinnitus presence					5.9%
Intercept	5.85	0.18	32.41	< 0.001
Age (years)	-0.02	0.01	-5.44	< 0.001
Bilateral CI (versus unilateral CI)	0.53	0.10	5.48	< 0.001
Tinnitus presence (versus tinnitus absence)	-0.71	0.09	-7.79	< 0.001
Model 2: tinnitus annoyance					8.4%
Intercept	5.84	0.18	32.78	< 0.001
Age (years)	-0.02	0.01	-5.51	< 0.001
Bilateral CI (versus unilateral CI)	0.55	0.10	5.77	< 0.001
Tinnitus level (versus tinnitus absence)
Not at all bothersome	0.32	0.22	1.44	0.149
Slightly bothersome	-0.35	0.14	-2.45	0.015
Quite a bit bothersome	-0.90	0.14	-6.23	< 0.001
Moderately bothersome	-1.00	0.17	-5.99	< 0.001
Extremely bothersome	-2.04	0.26	-7.71	< 0.001
Model 3: tinnitus annoyance change					7.8%
Intercept	5.85	0.18	32.66	< 0.001
Age (years)	-0.02	0.01	-5.51	< 0.001
Bilateral CI (versus unilateral CI)	0.53	0.10	5.58	< 0.001
Tinnitus change (versus tinnitus absence)
Much less bothersome	0.07	0.17	0.39	0.700
A little less bothersome	-0.64	0.16	-4.10	< 0.001
No change	-0.62	0.15	-4.02	< 0.001
A little more bothersome	-1.08	0.25	-4.35	< 0.001
Much more bothersome	-1.55	0.25	-6.24	< 0.001
Don’t recall it before surgery	-1.45	0.36	-4.02	< 0.001
Did not experience it before surgery	-1.32	0.27	-4.92	< 0.001
Bold indicates statistically significant p < 0.05.

Age and unilateral versus bilateral implants as covariates

There was no significant association between time with implant and the SSQ12 total scores (ANOVA test, F = 0.705, p = 0.49). Older age and unilateral (versus bilateral implants) were significantly associated with lower SSQ12 total scores in all models (p < 0.001, Table 5).

Association between hearing-related QoL and tinnitus status

The association between SSQ12 total scores and tinnitus presence is presented in Table 5 (Model 1). Recipients with tinnitus had significantly lower SSQ12 total scores than recipients without tinnitus (mean difference − 0.71 [SD: 0.09], F-test, p < 0.001, Supplementary Fig. S1) after adjusting for age and presence of unilateral/ bilateral implants. Using tinnitus presence as a predictive factor, Model 1 explained significantly more of the variability in SSQ12 total scores compared with the simplest Model 0, using only age and unilateral versus bilateral implants as predictors (Model 0 (R² = 3.4%) vs Model 1 (R² = 5.9%), ANOVA test, p < 0.001, Table 5).

Association between hearing-related QoL and self-reported tinnitus annoyance

The association between SSQ12 total scores and tinnitus annoyance is presented in Table 5 (Model 2). SSQ12 total scores significantly decreased with increased tinnitus annoyance (Jonckheere-Terpstra test, p < 0.001, Supplementary Fig. S2). Figure 2 shows Tukey pairwise comparisons of mean SSQ12 total scores between annoyance level groups. The mean difference in SSQ12 total scores between recipients without tinnitus and recipients rating their tinnitus as not at all bothersome was not significant at only − 0.32 (SD: 0.22) (Tukey test, p = 0.67, Supplementary Table S1). Recipients rating their tinnitus as not at all bothersome had significantly higher mean SSQ12 total scores than recipients with higher tinnitus annoyance levels (quite a bit bothersome: mean difference 1.23 [SD: 0.26], Tukey test, p < 0.001; moderately bothersome: mean difference 1.32 [SD: 0.27], Tukey test, p < 0.001; extremely bothersome: mean difference 2.36 [SD: 0.34], Tukey test, p < 0.001), except for tinnitus rated as slightly bothersome (Supplementary Table S1). Mean SSQ12 scores were significantly lower for tinnitus rated as extremely bothersome than for all other tinnitus annoyance levels (Tukey test, p < 0.001, Supplementary Table S1). Model 2, explained significantly more of the variability in SSQ12 total scores compared to Model 0 (Model 0 R² = 3.4% vs Model 2 R² = 8.4%, ANOVA test, p < 0.001).

Association between hearing-related QoL and perceived changes in tinnitus annoyance

The association between SSQ12 total scores and perceived changes in tinnitus annoyance since implantation is presented in Table 4 (Model 3) with Tukey pairwise comparisons shown in Fig. 3. SSQ12 total scores significantly decreased with increasing perceived changes in tinnitus annoyance (Jonckheere-Terpstra test, p < 0.001, Supplementary Fig. S3). Recipients rating their tinnitus as much more bothersome had significantly lower mean SSQ12 total scores compared with those rating their tinnitus as much less bothersome (mean difference − 1.62 [SD: 0.29], Tukey test, p < 0.001, Supplementary Table S1). Recipients reporting no change in tinnitus annoyance had significantly higher mean SSQ12 total scores than the ones with much more bothersome tinnitus (mean difference 0.93 [SD: 0.28], Tukey test, p = 0.02, Supplementary Table S1) and significantly lower mean SSQ12 total scores than those reporting much less bothersome tinnitus (mean difference − 0.68 [SD: 0.22], Tukey test, p = 0.03, Supplementary Table S1). Recipients with post-operative tinnitus who answered “I did not experience it before surgery” had significantly lower mean SSQ12 total scores than recipients without post-operative tinnitus (mean difference − 1.45 [SD: 0.36], Tukey test, p = 0.001, Supplementary Table S1) and recipients with much less bothersome tinnitus (mean difference − 1.38 [SD: 0.32], Tukey test, p < 0.001, Supplementary Table S1). Model 3, using perceived change in tinnitus annoyance as a predictor, explained significantly more of the variance in SSQ12 total scores compared with Model 0 (Model 0 R² = 3.4% vs Model 3 R² = 7.8%, ANOVA test, p < 0.001).

Relative importance of predictors

Figure 4 summarizes the relative importance of predictive factors in each model. In the three linear models, the predictor related to tinnitus was always most important: tinnitus presence (2.6% in Model 1, LMG method), tinnitus annoyance level (5.0% in Model 2, LMG method) or change in tinnitus annoyance (4.4% in Model 3, LMG method). Age contributed the least to each model (1.6% in Model 1, 2 and 3, LMG method).

Our data-driven approach assessed the relationship between the hearing-related QoL, the level of tinnitus annoyance, and also the perceived change in the level of tinnitus annoyance since cochlear implantation in 2322 adult CI recipients. The analysis demonstrated a statistically significant association between hearing-related QoL assessed by the SSQ12 and both tinnitus annoyance and perceived change in tinnitus annoyance at least one year after implantation. Overall, results suggested that CI recipients who experienced bothersome tinnitus showed worse subjective hearing-related QoL; whereas, CI recipients reporting less bothersome tinnitus since implantation had better hearing-related QoL. The SSQ12 total scores were also statistically significantly associated with the age of a recipient and presence of unilateral versus bilateral implants (Table 5). Coefficients of determination (R²) showed that only 8.4% of the variance in SSQ12 scores was explained by age, unilateral versus bilateral implantation and tinnitus annoyance levels. Therefore, it is highly likely that other important factors might contribute to the variations in SSQ12 scores.

Tinnitus prevalence was 33.9% in our cohort population, which is lower than the expected 40–54% prevalence found in previous studies on adult CI users ^9,18,24. The variability in tinnitus prevalence in CI users can be explained by a non-response bias in previous studies and variations in tinnitus definition and heterogeneous assessment methods to identify the presence of tinnitus ^2,25. This prevalence significantly varies with age (Table 4), as reported by other authors ^2,26−28. Based on the age group classification used in this study, tinnitus prevalence increases with age, with up to 38.6% for the recipients aged between 54 and 65 years old, and thereafter declines for older age group. The same trend was reported by previous studies using different cut offs and age groupings ^2,26.

Unilateral CI recipients reported significantly more tinnitus than bilateral CI recipients (Table 2). This is to be expected due to greater benefit with two implants compared with one ²⁹. However, levels of tinnitus annoyance do not significantly differ between unilateral and bilateral implants. This might suggest that two implants do not bring significant benefit in terms of tinnitus annoyance compared to a single implant. These findings, however, remain hard to interpret without detailed information about the tinnitus percept (e.g. location) and complementary information on recipients’ hearing loss profiles.

In our study, we used a validated multi-item questionnaire, the SSQ12, to measure hearing-related QoL ²². The SSQ12 has no question related to tinnitus. The total score ranges from 0 to 10, with 10 indicating a perfect hearing-related QoL. We found that SSQ12 total scores significantly decreased with increasing tinnitus annoyance. A mean difference of 2.36 points in SSQ12 total scores was found between CI recipients reporting their tinnitus as not at all bothersome and recipients with extremely bothersome tinnitus, which is more than double the clinically significant change of 1.0 SSQ points suggested by the SSQ developers ²¹. A mean difference in SSQ12 scores of the same range (2.55 SSQ12 points) was reported in a study investigating the difference between normal-hearing and hearing-loss groups ³⁰. Likewise, Wyss et al. showed a statistically significant improvement of 2.2 SSQ12 points at one-year post-implant in 1013 auditory implant recipients ³¹. Hence, the difference observed between the two extreme levels in tinnitus annoyance post-implantation showed the same magnitude of difference reported between pre-implantation and one-year post-implantation. The high mean differences found between different levels of tinnitus annoyance raises questions about the importance and the impact of tinnitus on hearing-related QoL in CI recipients, which may need further focus in clinics and exploration in future studies.

This study suggested a negative association between tinnitus and hearing-related QoL. When controlling for age and unilateral versus bilateral implants, mean SSQ12 scores were significantly lower in adult CI recipients with tinnitus than in CI recipients without tinnitus. Furthermore, tinnitus annoyance was also negatively associated with hearing-related QoL. The demonstrated association corresponds with the findings of previous studies investigating perceived tinnitus distress in CI recipients ^9,16−18. In a study from Opperman et al., an increase in perceived tinnitus distress was correlated with a decrease in hearing-related QoL based on the Abbreviated Profile of Hearing Aid Benefit (APHAB) scores ¹⁸. This is in line with our findings on perceived changes in tinnitus annoyance where CI recipients who experienced less bothersome tinnitus showed better subjective hearing-related QoL. This might be related to the impact of tinnitus on psychological distress such as stress, coping strategies and depressive and anxiety symptoms ^32,33, but also its impact on speech perception ³⁴; that is, both psychological and perceptual factors can affect hearing-related QoL. Moreover, SSQ12 scores were not significantly different between adult CI recipients experiencing tinnitus as not at all bothersome and CI recipients without tinnitus, highlighting the importance of tinnitus-related distress over the presence of tinnitus. Further research is needed to fully understand the factors involved in this relation and its implications on CI outcomes.

SSQ12 scores significantly decreased with age (Table 5). The age effect on SSQ or shorter forms was already observed in other studies examining minimally hearing-impaired subjects ³⁵ or CI recipients ⁹. Also, SSQ12 scores were significantly higher for bilateral CI recipients compared to unilateral recipients (Table 5). This association should be further investigated to assess if it could be related to other factors such as the implant side ^9,19 or patients’ hearing loss characteristics ³⁶.

Based on the models performed, 8.4% of the variance in SSQ12 scores was explained by age, unilateral versus bilateral implants and the level of tinnitus annoyance, with the latter being the most important predictor. Tinnitus annoyance and other tinnitus related characteristics deserve further research to understand what the causal relationship of the association is. The other 92% of the variance in SSQ12 scores could be potentially explained by differences in hearing impairment ^36,37, in speech perception performances ³⁸, in implant characteristics such as implant side ¹⁹ and in cognitive-linguistic performance such as listening effort ⁹. The influence of non-auditory aspects, such as education level ³⁶, socioeconomic level or additional comorbidities, should also be considered in explaining the variance in SSQ12 scores. Investigating the above characteristics and then adding the tinnitus variable would be a valuable approach to confirm or temper our findings.

The study cohort is derived from a multi-country database collected in a web-based survey platform. This unique database gathers tinnitus and individual characteristics from a large sample of 2322 Nucleus cochlear implant users. Therefore, the findings of the study are expected to be generalizable to the European adult cochlear implant population.

Some methodological issues in this study are worth considering. The first limitation is that the observational study design was not primarily aimed to study the effects of tinnitus. Due to limitations in the number of questions and length of the survey, only three questions were used to assess tinnitus characteristics. Furthermore, the question related to change in tinnitus annoyance addressed past experience, which could present a potential recall bias. In fact, CI recipients were asked to report the perceived change in tinnitus annoyance since implantation, which corresponded to a time interval of 3 years or more for 472 recipients, potentially increasing recall bias even further. Collecting prospective tinnitus outcomes pre-implantation and post-implantation would provide better insights in order to assess the change in tinnitus annoyance since implantation. In fact, the lack of longitudinal data limits the scope of our study to post-implantation tinnitus experience and prevents us from definitively estimating the effect of cochlear implant on tinnitus annoyance between pre- and post-implantation. Nevertheless, the retrospective design ensures that no adaptation process has taken place between the pre- and post-implantation periods by assessing changes at a given point in time and, thus, controlling for response shift ³⁹. Finally, we did not fully define tinnitus and other terms in the questions and answers ²⁵. For instance, the options related to the perceived change in tinnitus annoyance ”I did not experience it before surgery” and “I don’t recall it before surgery” could both be interpreted as reporting tinnitus newly after implantation. Therefore, these deliberations should be taken with caution since we did not have access to the pre-implantation tinnitus report to validate this interpretation.

Considering the clear association between hearing-related QoL and level of tinnitus annoyance, the identification of accompanying tinnitus should be a requirement in the standard CI candidacy evaluation. Clinicians and CI manufacturers should address tinnitus as an important factor to better manage patients’ expectation and ensure the benefit of CI. This study highlights a need for individualized tinnitus management therapies to be made available within CI counselling and rehabilitation. Further research is needed to determine the underlying mechanisms and relationships. Another aspect that will require further investigation is whether tinnitus annoyance has a direct impact on CI performance such as speech recognition.

Tinnitus prevalence was 33.9% post-implantation. This prevalence varied significantly with age, with the highest prevalence in middle age. CI recipients with tinnitus had a significantly lower SSQ total score than recipients without tinnitus. SSQ scores decreased significantly with increasing level of tinnitus annoyance and age. Overall, CI recipients who experienced less bothersome tinnitus showed better subjective hearing-related QoL. The association of better subjective hearing performance with a positive change in tinnitus annoyance after cochlear implantation should be further explored using a prospective study design and complementary associated factors. Furthermore, healthcare professionals may be well advised to give tinnitus management a higher priority for CI recipients in order for them to maximize the benefit of their CI.

Acknowledgement

We would like to thank CI recipients for agreeing to have their data collected for this study. We would also like to thank the Cochlear EMEA clinical team for managing the data capture and compliance.

Author contributions

K.K.S.A., R.A.G.J.A. and C.J. were part of the design of the manuscript. K.K.S.A, P.L.G. and C.J. were part of the design of the statistical analysis. K.K.S.A performed the analysis. K.K.S.A. drafted the manuscript. R.A.G.J.A., P.L.G., B.v.D. and C.J. substantively revised the work. All authors read and approved the submitted version.

Data available statement

The data that support the findings of this study will be available from the corresponding author, KKSA, upon reasonable request.

Funding

The study was sponsored by Cochlear Europe Limited.

Conflict of interest

K.K.S.A. received funding from the European Union’s Horizon 2020 research and innovation program under the Marie Sklodowska-Curie grant (agreement number 764604). K.K.S.A. and B.v.D. are employed at Cochlear Technology Centre Belgium, Mechelen, Belgium. R.A.G.J.A. is employed at Cochlear Benelux NV, Mechelen, Belgium. C.J. is employed at Cochlear France SAS, Toulouse, France. P.L.G. is a paid consultant for Cochlear Europe. No further conflict of interest is reported by the authors.

ORCID iDs

Kelly K.S. Assouly: 0000-0003-2667-9499

Chris James: 0000-0003-0273-5230

Petra L. Graham: 0000-0003-2890-2447

Remo A.G.J. Arts: 0000-0002-3716-379X

Bas van Dijk: 0000-0002-1864-2816

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Competing interest reported. K.K.S.A. received funding from the European Union’s Horizon 2020 research and innovation program under the Marie Sklodowska-Curie grant (agreement number 764604). K.K.S.A. and B.v.D. are employed at Cochlear Technology Centre Belgium, Mechelen, Belgium. R.A.G.J.A. is employed at Cochlear Benelux NV, Mechelen, Belgium. C.J. is employed at Cochlear France SAS, Toulouse, France. P.L.G. is a paid consultant for Cochlear Europe. No further conflict of interest is reported by the authors.

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Editorial decision: Major revision
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Reviewers agreed at journal
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You are reading this latest preprint version

Influence of tinnitus annoyance on hearing-related quality of life in cochlear implant recipients

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Version 1

Abstract

Figures

Introduction

Methods

Study population

Data collection

Survey

Ethical considerations

Statistical analysis

Results

Study population characteristics

Tinnitus profile

Age and unilateral versus bilateral implants as covariates

Association between hearing-related QoL and tinnitus status

Association between hearing-related QoL and self-reported tinnitus annoyance

Association between hearing-related QoL and perceived changes in tinnitus annoyance

Relative importance of predictors

Discussion

Conclusion

Declarations

References

Additional Declarations

Supplementary Files

Status:

Version 1