Keywords
deafness - cochlear implants - hearing aids - adult - speech
Introduction
Bilateral cochlear implants (CIs) are considered the gold standard to treat individuals
with severe to profound sensorineural hearing loss who do not benefit from hearing
aids (HAs). For patients who do not meet the criteria for bilateral implantation,[1] a solution could be bimodal stimulation, in which the patient uses a CI and an HA
contralaterally. Moreover, cases that have higher levels of contralateral residual
hearing may benefit from this solution. There are concerns regarding the selection
and adaptation protocols of HAs in bimodal stimulation.[2]
The literature has shown that bimodal stimulation is very advantageous and can improve
sound recognition in noisy environments,[2]
[3] as well as location of speech.[4] However, it has not been widely adopted. One of the main concerns is that there
is a difference between the sensations induced by the electrical stimulations through
the CIs and the acoustic stimulations through the HAs.[5]
According to Ching et al,[6] amplification in a non-implanted ear is important to prevent hearing deprivation
and the possible deterioration of speech recognition. Given the importance of bimodal
stimulation in patients who may benefit from HAs and in those who have not been offered
bilateral CIs, we need to be aware that loudness may be processed differently by the
CI and the HA.[7]
Scherf and Arnold[8] showed the HA gains, and the balance of the loudness of both devices was the most
common parameter that needed to be adjusted. Ching et al[9] recommend comparing the devices to identify the best frequency response to understand
speech and balance loudness. This then helps find the HA gain that best promotes an
auditory input at the same volume as that of the opposite side.
The balancing protocol for bimodal patients remains to be fully explored. Since the
indication for this adaptation has been growing with the expansion of the criteria
for CI indication, audiologists must have various options to ensure balance is achieved
between the HA and CI and to validate the programming of the devices. In the present
study, we considered binaural balance as an important factor that needed to be approached
when trying to achieve the best results from each device in users of bimodal stimulation.
Thus, the objectives of the present study were to evaluate if complex sounds present
in the limited frequency bands of the current devices enable the balance of loudness
in adult users of bimodal stimulation, and to analyze the improvement in speech recognition
after balancing.
Methods
The present prospective cross-sectional study was approved by the Ethics in Research
Committee of a tertiary hospital under CAPPesq number 941.254. The sample was randomly
selected using convenience sampling from patients examined between January 2014 and
November 2016.
The inclusion criteria were adult users of unilateral CIs and contralateral HAs for
at least six months, who were assisted in adjusting their contralateral HAs at the
hospital during the research period. They were selected and invited to participate
in the balancing protocol. The exclusion criteria were participants who used their
HAs inconsistently or who had difficulty in collaborating in the balancing protocol.
In total, 25 participants with bimodal stimulation agreed to participate in the study
after the purpose and procedures were explained. Of these, 16 were female, and 9 were
male, and all of them had attended the CI clinic between January 2014 and November
2016. The demographic data of these participants are shown in [Tables 1] and [2].
Table 1
Demographic data of the sample
|
Type of deafness: N (%)
|
|
Postlingual
|
19 (76%)
|
|
Prelingual
|
03 (12%)
|
|
Perilingual
|
03 (12%)
|
|
Electrode insertion: N (%)
|
|
Complete
|
23 (92%)
|
|
Incomplete
|
02 (8%)
|
|
Time of implant use (minimum-maximum)
|
32 (7–87) months
|
|
Average age (minimum-maximum)
|
46 (18–71) years
|
Table 2
Mean pure tone thresholds on the side with a hearing aid
|
250 Hz
|
500 Hz
|
1 kHz
|
1.5 kHz
|
2 kHz
|
3 kHz
|
4 kHz
|
6 kHz
|
8 kHz
|
|
Mean
|
82 dB
|
90 dB
|
99 dB
|
109 dB
|
105 dB
|
103 dB
|
105 dB
|
111 dB
|
118 dB
|
|
Minimum
|
20 dB
|
40 dB
|
70 dB
|
75 dB
|
75 dB
|
60 dB
|
65 dB
|
70 dB
|
70 dB
|
|
Maximum
|
130 dB
|
115 dB
|
120 dB
|
130 dB
|
130 dB
|
130 dB
|
130 dB
|
130 dB
|
130 dB
|
Note: A 130-dB absent response was used for statistical purposes.
The sample was composed of users of CIs made by every existing manufacturer: Med-El
(Innsbruck, Tyrol, Austria), 10 users; Oticon Medical (Vallauris, Alpes-Maritmes,
France) 6 users; Cochlear (Sydney, NSW, Australia); and Advanced Bionics (Valencia,
CA, USA) 2 users. Mapping data and information about the CIs are shown in [Table 3].
Table 3
Hearing device data
|
Patient ID
|
Cochlear Implant Speech Processor
|
Hearing Aid
|
Frequency allocation table (Hz)
|
Hearing Aid frequency limits (Hz)
|
|
S1
|
Opus 21
|
Chili 5SP5
|
100–8500
|
100–6500
|
|
S2
|
Opus 21
|
Xtreme 1216
|
100–8500
|
100–4000
|
|
S3
|
Opus 21
|
Naida s III SP7
|
350–8500
|
100–5000
|
|
S4
|
Opus 21
|
411 Extra7
|
100–8500
|
100–6800
|
|
S5
|
Opus 21
|
Chili 5SP5
|
100–8500
|
100–6500
|
|
S6
|
Saphyr2
|
Xtreme 1216
|
195–8008
|
100–4000
|
|
S7
|
Saphyr2
|
Naida III UP7
|
195–8008
|
100–5000
|
|
S8
|
Freedom3
|
Naida III UP7
|
188–7938
|
100–5000
|
|
S9
|
Harmony4
|
Chili 5SP5
|
250–8700
|
100–6500
|
|
S10
|
Saphyr2
|
Naida I SP7
|
195–8008
|
100–6900
|
|
S11
|
Naida CI4
|
Chili 5SP5
|
250–8700
|
100–6500
|
|
S12
|
Freedom3
|
Naida I UP7
|
188–7938
|
100–5000
|
|
S13
|
Nucleus 53
|
Xtreme 1216
|
188–7938
|
100–4000
|
|
S14
|
Opus 21
|
Naida I UP7
|
100–8500
|
100–5000
|
|
S15
|
Saphyr2
|
Naida I UP7
|
195–8008
|
100–5000
|
|
S16
|
Digi SP2
|
Naida S III SP7
|
195–8008
|
100–5000
|
|
S17
|
Saphyr2
|
Xtreme 1216
|
195–8008
|
100–4000
|
|
S18
|
Freedom3
|
Xtreme 1216
|
188–7938
|
100–4000
|
|
S19
|
Nucleus 53
|
Xtreme 1216
|
188–7938
|
100–4000
|
|
S20
|
Opus 21
|
Chili 5SP5
|
100–8500
|
100–6500
|
|
S21
|
Opus21
|
Sumo DM5
|
100–8000
|
100–5000
|
|
S22
|
Freedom3
|
Naida III SP7
|
188–7938
|
100–5000
|
|
S23
|
Opus 21
|
Xtreme 1216
|
310–8500
|
100–4000
|
|
S24
|
Opus 21
|
Sumo XP5
|
100–8500
|
100–5000
|
|
S25
|
Freedom3
|
Sumo DM5
|
188–7938
|
100–5000
|
Legend: 1-Med-EL (Innsbruck, Tyrol, Austria); 2-Oticon Medical (Vallauris, Alpes-Maritmes,
France); 3-Cochlear (Sidney, NSW, Australia); 4-Advanced Bionics (Valencia, CA, USA);
5-Oticon (Copenhagen, Denmark); 6-Bernafon (Bern, Switserland); 7-Phonak (Staefa,
Zurich, Switserland).
The following data were analyzed from the medical records: age, length of CI use,
model of the speech processor, length of HA use, and frequency table for CIs and HAs.
We also analyzed the free-field audiometry of the CIs and HAs before and after the
balancing protocol.
The balancing protocol was based on the one proposed by Ching et al.[9] The test was applied in an acoustic room with the computer's sound box at 0° azimuth
and the stimulus at 70 dB SPL. We used filtered instrumental sounds from a CD sonar
system (Carapicuiba, SP, Brasil) recorded at the following frequency bands: 500 Hz
and 700 Hz, and 1 kHz, 2 kHz, 3 kHz, 4 kHz, and 8 kHz.[10] The participants, using the two devices simultaneously (HA and CI), were asked to
report if the sound was perceived equally or if it was louder in one of the ears.
The prescription of HA followed the National Acoustic Laboratories' nonlinear fitting
procedure, version 1 (NAL-NL1),[11] or the desired sensation level (DSL),[12] according the preference of the participant.
The sounds were first presented in the initial HA settings used by the participant.
After the unbalanced frequencies were identified, adjustments were made to the HA
gain or maximum output. To achieve balance between the devices, those adjustments
were made through either increasing or decreasing the HA volume to equate it with
the IC volume.
The participants were already users of HAs, and the prescription and configuration
were verified using the GN Otometrics Aurical Plus equipament (Taastrup, Denmark)
with an in situ probe in the ear contralateral to the one with the CI. After the balancing adjustments,
the verification of the prescription target was repeated.
To analyze the gain from the frequency bands in the different HA brands, the frequency
bands were chosen as bass, medium, and high, and grouped according to the following
frequencies: low frequency, 250 Hz or 300 Hz; mid-frequency, 1,000 Hz or 1,500 Hz;
and high frequency, 3,500 Hz or 4,000 Hz.
We analyzed the speech recognition test results using the participant's performance
before and after the balancing protocol. This data was collected as part of the CI
care routine.[13] The difficulties in speech recognition evaluation were in accordance with the performance
of the participants. The sentences conducted in silence (closed or open set)[14] were performed in the free field at 0° azimuth and at 65 dB SPL, and/or the sentences
in noise with a signal to noise ratio (SNR) at 0 dB or +10 dB.
The data was collated in Microsoft Excel (Microsoft Corp., Redmond, WA, US) spreadsheets
and analyzed with the BioEstat (Belem, PA, Brasil) software, version 5.3, using descriptive
statistics and a paired t-test. Values of p < 0.05 were considered statistically significant.
Results
Out of the 25 participants, 5 failed to achieve balance at every tested frequency,
and 3 reached equilibrium at almost every frequency, except for 8,000 Hz ([Table 4]). We observed no statistical difference between the pure tone audiometry (PTA) means,
the length of use, and the characteristics of the HAs.
Table 4
Participant data organized by the results of the loudness balancing test
|
Achieved balance in every frequency
(n = 17)
|
Achieved balance in every frequency, except 8 khz
(n = 3)
|
Achieved balance only in 4 to 6 frequencies (n = 5)
|
|
PTA (dB HL)
|
96
|
94
|
107
|
|
Minimum
|
40
|
80
|
90
|
|
Maximum
|
130
|
120
|
130
|
|
Time of CI use (months)
|
|
|
|
|
Mean (minimum–maximum)
|
36 (7–87)
|
22 (16–31)
|
24 (7–52)
|
|
HA fitting parameters
|
|
Mean minimum frequency (Hz)
|
100
|
100
|
100
|
|
Mean maximum frequency (Hz)
|
5218
|
5500
|
4800
|
|
Frequency range
|
Low
|
Mid
|
High
|
Low
|
Mid
|
High
|
Low
|
Mid
|
High
|
|
Mean MPO (dB)
|
111
|
122
|
117
|
111
|
119
|
110
|
118
|
128
|
122
|
|
Mean gain (dB)
|
46
|
53
|
44
|
48
|
53
|
41
|
55
|
60
|
46
|
Abbreviations: CI, cochlear implant; HA, hearing aid; MPO, maximum power output; PTA,
pure-tone average.
All participants underwent in situ verification to confirm changes to the HA after
balancing, except for one participant in whom the verification could not be performed
due to technical problems with the equipment. Almost all of the participants were
able to maintain the target settings for the prescription, except for three participants
in whom it was not possible to reach the target suggested by the software in order
to ensure the participant's auditory comfort. Out of the 25 participants, 7 chose
the DSL prescription.
After the statistical analyses, a significant difference was observed between the
speech recognition tests conducted before and after balancing in silence in twenty
participants with complete data. However, there were no statistical differences in
speech recognition before and after balancing in a noisy environment ([Table 5]). In total, 4 participants had a worse performance regarding speech recognition,
and 2 did not experience any changes after balancing the loudness. These participants
were not in the group that failed to achieve balance in more than seven of the tested
frequencies.
Table 5
Speech recognition in silence and in noise before and after loudness balancing
|
Before balancing
|
After balancing
|
p-value
|
|
Speech in silence (
n
= 20)
Mean
|
67%
|
75%
|
0.044*
|
|
Standard deviation
|
35.7
|
32.5
|
|
Speech in noise (
n
= 16)
Mean
|
30.6%
|
41.2%
|
0.0972
|
|
Standard deviation
|
39.5
|
36.6
|
Note: *Statistically significant value (p < 0.005, paired t-test).
Discussion
The main objective of the present study was to verify the possibility of using narrow
complex sounds as a balancing protocol for users of bimodal stimulation. As a result,
the use of narrow complex sounds seems to be able to produce a bare loudness balance
for patients with profound hearing loss and little residual hearing. However, the
best option would be speech material that can be directed to the patient's comprehension.
Ching et al[6] presented a recorded story in the sound field to equalize the loudness of the speech
between the ears. In the present study, the hypothesis was to use limited complex
sounds due to the restricted access to speech sounds in the ear contralateral to the
one with the CI. This topic is interesting as the population tends to improve their
residual hearing, and it should be considered in future studies.
Most of the participants achieved sound equalization in every evaluated frequency,
along with an improvement in speech recognition after balancing.
Since the present study performed a qualitative analysis of a convenience sample,
it was not possible to confirm that the study population accurately represents the
population of implanted patients who use bimodal stimulation at this CI Center. Moreover,
the participants were users of different brands of CI and HAs. However, the results
we obtained could be used to program the speech processor and contralateral HA, as
it was possible to perform the balancing protocol in different brands of CIs and HAs.
It was also possible to perform the balancing of loudness in pre-, peri- and postlingual
patients, because the comparison of the results was performed with the participants
themselves.
Several studies[15]
[16]
[17] with patients using bimodal stimulation show that residual hearing is a factor that
contributes to using a contralateral HA and CI. Devocht et al[15] showed that the group that remained with an HA after one year of CI use had a 3-frequency
pure-tone average (PTA) of 92.3 dB HL. Moreover, Neuman and Svirsky[16] showed that HAs are best used in patients who have up to 95 dB HL and up to 2 kHz.
Conversely, Neuman et al[17] reported that patients who had stopped using HAs were those with a PTA lower than
99.2 dB HL. In the present study, we offered a balanced fitting, which enabled the
patients to benefit from bimodal stimulation even if their average contralateral hearing
was of 98 dB HL.
The present study showed that the new balancing protocol was feasible in the whole
sample. The loudness balance was achieved in almost all of the participants. However,
eight participants were not able to achieve the same loudness in both ears in one
or more frequencies.
The balance of the loudness of the two devices has been described as a major issue
in optimizing the fitting. As Scherf and Armold[8] mentioned, we believe that CI centers should be prepared and equipped to perform
the procedure to optimize both hearing devices.
Since complex sounds are more easily perceived by patients with less residual hearing,
this protocol using complex sounds was easy to apply and did not alter the overall
time of patient care, since it was performed at the same time as the HA was adjusted.
Ideally, we believe that bimodal patients can have speech processor mapping and the
HA adjustment performed together to help balance the loudness between the two devices.
Although ideally both devices will be adjusted, Ching et al[9] emphasized in their study the possibility of applying the balancing protocol either
during the HA adjustment or CI fitting.
Dividing the sample according to the results of the balancing protocol, we observed
that the groups were heterogeneous regarding the number of participants. However,
we noted that the participants with more residual hearing achieved balancing in either
all of the frequencies or in almost all of them, except for 8,000 Hz. The HAs of the
participants who did not achieve balance had a narrower frequency range and higher
gain and maximum output values, which is a consequence of greater hearing loss ([Table 4]). It would be interesting to study a larger sample to observe if this is an actual
trend and if these HA characteristics could facilitate balancing. For example, a study
by Neuman and Svirsky[16] showed that the HA frequency band is essential for balance.
It was also interesting to observe the HA prescription rule, since seven participants
preferred the DSL either because they were already users of it before the CI surgery,
or because they had better results with it. Almost all of these participants were
able to achieve balance at all frequencies, except for 1 participant who was not able
to balance at 8,000 Hz. Ching et al[9] recommended the NAL-NL1 prescription as a good starting point to fit an HA to a
non-implanted ear. Individual fine-tuning of the gain-frequency response can be performed
after fitting. Therefore, each case must be considered and offered a tailored HA adjustment
option that will give the patient the best results.
Balanced loudness at the 8,000-Hz frequency cannot be expected, since it is a frequency
that is not provided by the HA. Therefore, the CI side should be louder. Perhaps,
as most participants had a sense of balance at every frequency, they felt that the
frequency of 8,000 Hz was balanced as well. In cases that did not achieve balance
at this frequency alone, 2 out of 3 of the participants improved their speech recognition
after balancing. This emphasizes the importance of performing loudness balancing and
speech recognition tests on each hearing device separately and together.
Regarding speech recognition, the performance of some participants worsened after
balancing. Interestingly, they were not those who failed to achieve loudness balance.
A bias of our analysis was the time between the pre- and post balancing evaluation,
since the tests were performed in a routine-care setting at the CI Center, where we
needed to respect the proposed schedule for speech-processor programming. Thus, the
mean time between the test before and after the loudness balancing was 11 months,
ranging from 1 day to 24 months. Nevertheless, this time was similar among the groups.
When we separated the groups by their speech recognition results, the group with the
best performance also had an average of 11 months, and the group with the worst performance
had an average of 12 months.
The statistical analyses showed that, on average, the participants improved their
speech recognition performance in silence after loudness balancing. There were no
statistically significant differences when we performed separate analyses for the
participants who did not achieve sound balancing. Thus, we can assume that the balance
of loudness may have contributed to the improvement in test results in the bimodal
condition. Although studies also show that there is a benefit of bimodal stimulation
in both silence[2]
[3]
[4] and noise,[2]
[17] no research has been found that evaluates speech recognition after a balancing protocol.
Therefore, it is important to increase the sample size and to validate these results
with speech recognition tests in both conditions.
In the present study, there were no statistically significant differences regarding
speech recognition in noise. This may be explained by the fact that HAs contribute
little to the access of speech sounds in participants with a mean PTA of 96 dB. In
many cases, the participants would be considered candidates for a second CI. However,
at the time of the present study, the priority for bilateral implantation was children
up to 4 years old, or cases cited as exceptions. Even though, as bilateral CIs were
not a possibility for adults, bimodal stimulation could be an option to maintain the
stimulation of the auditory pathway. Another explanation can be found in the HA technology
for difficult listening situations. We know that, for binaural hearing, communication
between the two ears is essential, so communication between the electronic devices
is equally important.
[Fig. 1] shows two interesting analyses. First, it shows that eight participants had worse
performances with the HA after balancing. However, they found improvements in the
bimodal condition. Two participants that had postlingual deafness, both with etiology
of meningitis, had worse performances only with the CI, showing the importance of
more frequent follow-ups in these cases, especially when a drop in performance occurs.
Another interesting case was a participant with progressive deafness who had difficulty
answering the questions about the device settings, which could have interfered with
the participant's responses, despite the fact that they had experience using both
devices (51 months with the CI).
Fig. 1 Speech recognition results after loudness balancing.
Thus, we believe that speech-recognition tests are vital. These should be evaluated
more frequently, as poor performances on speech tests may be a precursor to abandon
the use of the HA. Neuman et al[17] asserted that almost all patients who discontinued their use of the HAs had relatively
low performances in their speech recognition test. In these participants, the bimodal
conditions (CI + HA) were not significantly better than with the CI alone. An audiogram
analysis alone could not predict whether the participants would continue to use the
contralateral HA.
Lastly, there was a case of postlingual deafness in which even after further HA adjustments,
the participant did not show improvements in the bimodal stimulation and complained
about the regulation of the HA. After this, further adjustments were made. Moreover,
this participant had been using the CI for 9 months, showing that they were still
adapting to the new auditory stimuli.
Thus, we suggest that CI manufacturers should include a bimodal fitting procedure
in the CI fitting software to make the balancing procedure easier and to aid their
implementation in the routine clinical practice.[8] Furthermore, communication between HAs and speech processors has been increasingly
studied.[18] There are concerns regarding the ability of the two devices, HA and CI, to work
together. Thus, the development of balancing protocols between the devices is very
important to integrate the two devices and validate device adjustments.
Conclusion
A loudness balancing protocol with narrow complex sounds presented in the frequency
bands of the devices helped adult users of bimodal stimulation to improve their speech
recognition.