1. Introduction
Cochlear implantation is an efficient treatment for postlingually deafened adults with severe and profound hearing loss. In particular, a cochlear implant (CI) is indicated when the benefit from acoustic amplification is insufficient [
1,
2,
3,
4,
5,
6,
7]. For mild and moderate hearing loss, a hearing aid (HA) is the option of choice, while for higher degrees of hearing loss it must be carefully considered which approach is better. Especially in the transition range, i.e. hearing thresholds better than 80 dB
HL (dB hearing loss), the variability of the aided speech recognition is substantial [
8,
9,
10,
11,
12,
13,
14,
15,
16,
17]. Nevertheless, in individual cases the speech recognition with HA can be assessed preoperatively. However, the large variability in CI outcome as assessed by word recognition scores with CI [
18,
19,
20,
21,
22] represents a major obstacle: For the patient population with benefit from HAs the
individual prediction is of major importance, as the patient and the professional have to balance the residual aided word recognition with the HA, the expected word recognition with CI, the expected improvement in quality of life, and the impact of CI surgery. Some studies have also included subjects with lesser hearing loss (e.g. <80 dB
HL) who were considered likely to benefit from cochlear implantation [
5,
6,
17,
23,
24,
25,
26,
27,
28,
29]. A retrospective analysis [
22] of 312 postlingually deafened adult CI recipients yielded the preoperative maximum word recognition score (WRS
max) as a predictor for the minimum WRS with CI at conversation level, WRS
65(CI). The importance of this preoperative measure was confirmed by two studies including respectively 128 [
28] and 664 [
17] cases. In an earlier study we addressed explicitly the prediction of WRS
65(CI) in a population with hearing losses of less than 80 dB
HL only [
6]. This retrospective analysis led to a generalised linear model (GLM) that provides an estimated prediction of WRS
65(CI) six months after implantation on the basis of three preoperatively known factors: the WRS
max, the patient's age at implantation, and the aided WRS at conversation level, WRS
65(HA), according to equation 1.
with
β0 = 0.84 ± 0.18,
β1 = 0.012 ± 0.0015,
β2 = –0.0094 ± 0.0025 year
-1 and
β3 = 0.0059 ± 0.0026; all WRS expressed in %.
Figure 1 illustrates the characteristics of this GLM. The WRS
max accounts for up to 27 percentage points (pp) in WRS
65(CI) differences. The WRS
65(HA) influences the prediction by up to 9 pp, while age at implantation is associated with a deterioration of up to 17 pp. The GLM resulted from an analysis based on a population of 128 postlingually deafened adult CI recipients, all with a preoperative hearing loss equal to or less than 80 dB
HL as measured by the hearing loss at 0.5, 1, 2 and 4 kHz (four-frequency pure-tone average, 4FPTA).
The prediction error of the model as described by the median absolute error (MAE) was found to be 13.5 pp [
6], with one-quarter of the study population scoring 12 pp or more below prediction. A subsequent prospective study [
29] confirmed the applicability of the model for CI recipients within certain boundary conditions: for a patient population with a preoperative WRS
max greater than zero, a prediction error of 11.5 pp was found. Only 6% (5/85) of the recipients missed the predicted score by more than 20 pp within one year after implantation. As shown in
Figure 1, the output range is limited to scores between 49% and 90%. This is due to the fact that patients with significant residual hearing are most likely to perform in this range [
6,
17,
22,
28,
29]. This is not the case for the application of the model in a population with preoperative WRS
max = 0%; that, as expected, resulted in a higher prediction error of 23.2 pp. If both WRS
max and WRS
65(HA) are zero, the prediction from equation (1) is based solely on the patient's age, represented by β
2, and the population mean outcome, represented by β
0.
While in some previous analyses duration of deafness (DoD) played a significant role [
19], DoD was not included in the model (Eq. 1). This is due to the fact that only subjects with hearing threshold better than 80 dB
HL were included. Holden et al. [
20] showed that the duration of hearing impairment (DHI) is a factor that contributes to speech recognition with CI. Additionally, DHI is applicable for subjects with residual hearing, regardless of the degree of hearing loss.
The goal of this study was the extension and evolution of the model [
6] in order to improve the prediction, especially for the patient population with a preoperative WRS
max of zero. The design requirements for the model were defined as follows: Since equation 1 has proved its applicability [
29,
30] the coefficients β
0–3 remained fixed. Only preoperative measures were to be included in the model. Additionally, these measures were to be subsets of clinical routine measurements within the CI candidate assessment according to the German CI Guidelines [
3] and the German white book CI provision [
4].
4. Discussion
The vast majority (89%) of the patients included in this study showed significantly improved speech recognition without any patient experiencing a lower WRS six months after cochlear implantation.
Both populations (patients with preoperative WRS
max larger than zero, group 1, and patients with preoperative WRS
max equal to zero, group 2) showed a median WRS
65(CI) of 70%. However, as illustrated by
Figure 4, the variability of the outcome was greater for group 2, and the mean WRS
65(CI) was smaller: 59% in group 2, compared with 68% in group 1.
The extension of the prediction model for CI outcome in CI recipients with preoperative WRS
max = 0 is feasible. It was shown that for group 2 an improved prediction is possible without impairment of the prediction for group 1. Most remarkably, the inclusion of just one additional input variable (the duration of unaided hearing impairment, DuHI) in the previous prediction model for the WRS
65(CI) [
6] resulted in a decreased prediction error for group 2: The new GLM (equation 2) resulted in a decreased MAE of 17.0, compared with the MAE of the previous model (equation 1) of 23.7 pp. The prediction error for group 1 remained almost unchanged. The new model indicates a slightly decreased MAE of 11.1 pp, compared with 11.4 obtained from the previous model [
6].
The durations of hearing impairment and unaided hearing impairment, DHI and DuHI, were found to be strongly correlated (RSpearman = 0.7). Hence, they may provide similar information on the CI outcome. The ablation analysis showed that the MAE was not greatly increased when DHI or DuHI was omitted. We decided to retain the latter, because DHI was found as not significant (p=0.16) in the presence of DuHI. Additionally, the MAE was smaller for both groups when DuHI is used instead of DHI (equation 2). However, the DHI offers some advantages. The DHI is just defined by one time point, the time of onset of hearing loss, while determination of DuHI requires knowledge of two time points – of HA provision and of onset of hearing loss. Yet both factors depend on the patient's ability to remember or reconstruct events which may well have occurred decades earlier. In summary, the model according to equation 3 inherits larger MAE. However, equation 3 and therefore the DHI may be used in cases where DuHI is not available.
In this study the DHI replaces the previously used duration of deafness, DoD, for several reasons. Regarding DoD, an obsolete classification [
37] refers to a cut-off of 81 dB
HL for the grade “profound impairment including deafness”. A more recent classification [
38] defines “Complete or total hearing loss/deafness” via a hearing threshold in the better ear of 95 dB
HL or greater. As already pointed out by those authors [
38] “the classification and grades are for epidemiological use”. For prediction models and clinical process management, to our knowledge, there is a lack of applicable, defined criteria for cut-off relating to the duration of deafness and hearing impairment. Additionally, in the presence of a decentralised hearing health care system (e. g. in Germany) the chance of obtaining a precise assessment is rather low. In our population of consecutive Nucleus CI provisions in adults within a period of 2.5 years, only 42% exhibited a 4FPTA of ≥95 dB
HL in the ear to receive the implant, so that a broader application of DoD in a regression model is not relevant. On the other hand, in this subpopulation (numbering 69 patients), about one-third had a measurable ipsilateral maximum recognition score for Freiburg words and slightly under one-half had a measurable speech recognition threshold for Freiburg numbers in quiet. This supports the preference for functional, speech-related variables instead of DoD.
There was a slight decrease in MAE for group 1 only (preoperative WRS
max > 0). This can be interpreted as giving strong support to the use of the WRS
max for predictive purposes [
6,
17,
22,
28], as it accumulates the detrimental effects of long DHI (or DuHI). The situation is different in group 2 (preoperative WRS
max = 0) where such functional assessment with the established test WRS
max and WRS
65(HA) is not possible. Here the additional information of DuHI or DHI considerably reduces the prediction error.
According to the design requirements, the regression analysis using the GLM was conducted across all data by using all data in a first attempt. The effects of these three variables upon the prediction error are different. It was found that the SRT
num did not decrease the MAE. Hence, SRT
num was not taken into account any longer, which however does not necessarily mean that this variable is unimportant. Together with the strong correlation with WRS
max and WRS
65(HA) this indicates an over-determined equation system. Nevertheless, especially for cases with no preoperative monosyllable speech perception it might be a useful addition. In our population only about one-quarter of group 2 had a measurable SRT
num. Perhaps an additional split beyond groups 1 and 2 will improve the prediction with the help of SRT
num in a clearly and more narrowly defined population. On the other hand, other model approaches – such as random forest regression – would induce such a split per se. However, more data would be needed for such approach. In a recent study, Rieck et al. [
17] used the Freiburg numbers and found a predictive value in a population of nearly 500 recipients. Two characteristics of their study population would support the assertion of a positive impact of SRT
num on prediction error in a population with low preoperative speech perception in general. The mean values obtained in their study represent the characteristics of an established patient population with a preoperative mean WRS
65(HA) of 4.2% compared with 9.7% and a WRS
max of 11.8 compared with 27.6% in this population. Rieck et al. [
17] included clinical data with implantations dating from 2002 to 2019, while the inclusion period of the present study was from 2020 to 2022. Consequently, this relationship should be reconsidered in future studies that include more CI candidates who are in group 2 but who have measurable SRT
num.
5. Conclusions
Cochlear implantation can be considered if speech recognition with hearing aids is insufficient. This applies also for patients with pure-tone hearing loss in the range of 60 dBHL. The preoperative prediction of expected word recognition after CI provision is possible within clinically relevant limits.
Less variable results for postoperative word recognition were observed in patients with preoperative maximum word recognition greater than zero (group 1) compared with patients without preoperative maximum word recognition (group 2).
The inclusion of additional model input variables – ‘duration of hearing impairment’ or ‘duration of unaided hearing impairment’ – to the variables ‘word recognition scores‘ and ‘age at implantation‘ already used in the model resulted in decreased prediction errors for group 2. However, the prediction error in group 2 was still larger than in group 1. In group 1 the inclusion of additional input variables did not result in a lower prediction error.
We believe that this model will be applicable in preoperative counselling (with a higher accuracy in group 1 than in group 2) and will also be useful in CI aftercare, to support the systematic monitoring of CI fitting that is conducted to optimise postoperative adjustment.