Search

This paper reviews methods and considerations for measuring tinnitus in clinical trials designed to evaluate treatment options using investigational medicinal products. Tests applied in tinnitus-related research and clinical practice have their own measurement purposes, advantages, and limitations. If the characteristics of each test method are well understood, the test can be effectively used in clinical trials. For the accuracy of clinical trial results, it is necessary to use a test tool with verified validity, reliability, and sensitivity. If a test tool that is likely to have high variability in the same individual is required in the clinical trial, strategies to increase the reliability of the test, such as repeat measurements, may also be needed. In addition, a test tool that meets the purpose of the clinical trial should be selected. For example, the tinnitus questionnaire is appropriate to assess reactions to tinnitus, and measurements of tinnitus loudness or pitch are appropriate to evaluate the psychoacoustic characteristics of tinnitus. In conclusion, the use of validated test tools that meet the purpose of the trial will help with the accuracy of the clinical trial results.

Five bilateral cochlear implant users were tested for their localization abilities and speech understanding in noise, for both monaural and binaural listening conditions. They also participated in lateralization tasks to assess the impact of variations in interaural time delays (ITDs) and interaural level differences (ILDs) for electrical pulse trains under direct computer control. The localization task used pink noise bursts presented from an eight-loudspeaker array spanning an arc of approximately 108 degrees in front of the listeners at ear level (0-degree elevation). Subjects showed large benefits from bilateral device use compared to either side alone. Typical root-mean-square (rms) averaged errors across all eight loudspeakers in the array were about 10 degrees for bilateral device use and ranged from 20 degrees to 60 degrees using either ear alone. Speech reception thresholds (SRTs) were measured for sentences presented from directly in front of the listeners (0 degrees) in spectrally matching speech-weighted noise at either 0 degrees, +90 degrees or -90 degrees for four subjects out of five tested who could perform the task. For noise to either side, bilateral device use showed a substantial benefit over unilateral device use when noise was ipsilateral to the unilateral device. This was primarily because of monaural head-shadow effects, which resulted in robust SRT improvements (P<0.001) of about 4 to 5 dB when ipsilateral and contralateral noise positions were compared. The additional benefit of using both ears compared to the shadowed ear (i.e., binaural unmasking) was only 1 or 2 dB and less robust (P = 0.04). Results from the lateralization studies showed consistently good sensitivity to ILDs; better than the smallest level adjustment available in the implants (0.17 dB) for some subjects. Sensitivity to ITDs was moderate on the other hand, typically of the order of 100 micros. ITD sensitivity deteriorated rapidly when stimulation rates for unmodulated pulse-trains increased above a few hundred Hz but at 800 pps showed sensitivity comparable to 50-pps pulse-trains when a 50-Hz modulation was applied. In our opinion, these results clearly demonstrate important benefits are available from bilateral implantation, both for localizing sounds (in quiet) and for listening in noise when signal and noise sources are spatially separated. The data do indicate, however, that effects of interaural timing cues are weaker than those from interaural level cues and according to our psychophysical findings rely on the availability of low-rate information below a few hundred Hz.

This study examined the average and individual performance over time of 49 adult cochlear implant subjects. Subjects were randomly assigned to receive either the Ineraid cochlear implant, with analog processing, or the Nucleus cochlear implant, with feature-extraction processing. All subjects had postlingual profound bilateral sensorineural hearing loss and received no significant benefit from hearing aids before implantation. Group data were examined in two ways. First, only subjects who had complete data over the test period were examined. Second, an analysis of all available data was carried out by mixed linear-model analysis. In this analysis, to account for missed follow-ups at the planned intervals, data consisting of the observations closest in time to the planned test times were modeled by natural splines with knots at the planned follow-up times. Contrasts between all pairs of planned follow-up times for each device were tested, as were contrasts between devices at each planned follow-up time. Results indicated little difference between the performance of the Ineraid and Nucleus subjects in their level of performance or their rate of learning. Postimplantation performance was typically superior to preimplantation performance within 9 months, and continued to improve up to 18-30 months depending on the speech perception measure. In some subjects, improvements in speech perception measures were observed up to four or five years postimplantation. There was also evidence that three subjects had a decrement in overall speech perception performance, although their postimplantation scores were always higher than their preimplantation scores. In at least one subjects this was likely a result of age-related cognition decrements.

Fifty-four of the better cochlear-implant patients from Europe and the United States were tested on two consonant recognition tests using nonsense syllables. One was produced in an accent appropriate for their own language by a male and a female talker. Recorded tokens of /ibi, idi, igi, ipi, iti, iki, ifi, ivi, ifi, isi, izi, imi, ini/ were presented. With the French syllables, six patients with the Chorimac device averaged 18% correct (6%-29%). With the German syllables, nine patients with the 3M/Vienna device averaged 34% correct (17%-44%), ten patients with the Nucleus device (tested in Hannover) averaged 31% correct (19%-42%), and ten patients with the Duren/Cologne device averaged 27% correct (10%-56%). With the English syllables, ten patients with the Nucleus device (tested in the United States) averaged 42% correct (29%-62%), and nine patients with the Symbion device averaged 46% correct (31%-69%). An information-transmission analysis and sequential information-transfer analysis of the confusions suggested that different implants provided differing amounts of feature information. The place of articulation feature was typically the most difficult to code for all implants. In the second test a male and a female talker recorded the stimuli /ibi, idi, igi, imi, ini, ifi, isi, izi/ in a single manner that was appropriate for all three languages. Six patients with the Chorimac device averaged 27% (13%-48%), ten patients with the Duren/Cologne implant averaged 29% (15%-75%), ten patients with the Nucleus device (tested in Hannover) averaged 40% (25%-58%), ten patients with the Nucleus device (tested in the United States) averaged 49% (40%-60%), nine patients with the Symbion device averaged 61% (40%-75%), and nine patients with the 3M/Vienna device averaged 41% (29%-52%) correct.

Thresholds for 2-kHz sinusoidal signals were determined in the presence of a notched-noise masker, for six normal-hearing listeners and 12 listeners with cochlear hearing losses. Following Patterson and Nimmo Smith [J. Acoust. Soc. Am. 67, 229-245 (1980)], conditions were used where the notch was placed both symmetrically and asymmetrically about the signal frequency. The auditory filter shape for both the low- and high-frequency side of the filter was calculated using the rounded-exponential form of the filter. In six hearing-impaired listeners, the auditory filter shape showed a shallow low-frequency skirt indicating pronounced susceptibility to the upward spread of masking. In two hearing-impaired listeners, the filter shape showed a shallow high-frequency skirt, indicating pronounced susceptibility to the downward spread of masking. Two other listeners with mild threshold losses had steeper and more symmetric filters than normal, suggesting either a small conductive loss or an attenuation factor of sensorineural origin not associated with a degradation of frequency resolution. In the remaining two listeners, the auditory filter had too little selectivity for its shape to be reliably determined.

Several studies using bandlimited masking noise have indicated that NOSO frequency resolution is better than that for NOS pi. The present study examined NOSO and NOS pi frequency resolution with two different masking methods: bandlimited noise and notched noise. Noise spectrum levels of 10, 30, and 50 dB/Hz were used. Thresholds were determined for a 500-Hz signal, using a three-alternative forced-choice adaptive procedure, as a function of masker bandwidth and notchwidth. For NOSO presentation, 3-dB down points were comparable for the notched-noise and bandlimiting methods. For NOS pi presentation, 3-dB down points were generally greater for the bandlimiting method than the notched noise method. Furthermore, for NOS pi presentation, the 3-dB down estimate increased as noise level increased for the bandlimiting method, but stayed constant for the notched-noise method. It is suggested that the two masking methods measured different aspects of binaural processing.

The ability to recognize synthetic, two-formant vowels with equal duration and similar loudness was measured in five subjects with the Cochlear and five subjects with the Symbion cochlear implants. In one set of test stimuli, vowel pairs differed only in the first-formant frequency (F1). In another set, vowel pairs differed only in the second-formant frequency (F2). When F1 differed, four of five Cochlear subjects and four of five Symbion subjects recognized the vowels significantly above chance. When F2 differed, two of five Cochlear subjects and three of five Symbion subjects scored above chance. These results suggest that implanted subjects can utilize both "place" information across different electrodes and "rate" information on a single electrode to derive information about the spectral content of the stimulus.

Frequency resolution and three tasks of frequency discrimination were measured at 500 and 4000 Hz in 12 normal and 12 hearing-impaired listeners. A three-interval, two-alternative forced-choice procedure was used. Frequency resolution was measured with an abbreviated psychoacoustical tuning curve. Frequency discrimination was measured for (1) a fixed-frequency standard and target, (2) a fixed-frequency standard and a frequency-transition target, and (3) frequency-transition standard and a frequency-transition target. The 50-ms frequency transitions had the same final frequency as the standards, but the initial frequency was lowered to obtain about 79% discrimination performance. There was a strong relationship between poor frequency resolution and elevated pure-tone thresholds, but only a very weak relationship between poor frequency discrimination and elevated pure-tone thresholds. Several hearing-impaired listeners had normal discrimination performance together with pure-tone thresholds of 80-90 dB HL. A slight correlation was found between word recognition and frequency discrimination, but a detailed comparison of the phonetic errors and either the frequency-discrimination or frequency-resolution tasks failed to suggest any consistent interdependencies. These results are consistent with previous work that has suggested that frequency resolution and frequency discrimination are independent processes.

This experiment investigated some interactions between combination tones (CT) and unmasking. Data were obtained from nine normal-hearing listeners in a forward-masking paradigm in which a 2000-Hz, 35-dB SPL masker preceded a 2000-Hz test signal. An adaptive, three-interval forced-choice procedure was employed to estimate the threshold for the test signal. This measurement provided a baseline. When a second sinusoid, the suppressor, of variable frequency and 55 dB SPL was presented concurrently with the masker, the amount of masking could be less than in the baseline condition. This two-tone unmasking was observed when the suppressor was approximately 2300 Hz. In the cubic difference tone (CDT) condition, two higher-frequency sinusoids of 80 dB SPL (with the lower frequency fixed at 2800 Hz) were added to the masker. In the difference tone (DT) condition, two higher-frequency sinusoids of 100 dB SPL (with the lower frequency fixed at 3500 Hz) were added to the masker. None of these sinusoids produced unmasking when presented individually, but when the CDT and DT were approximately 2300 Hz, unmasking was observed. The unmasking produced by the CTs was similar in its frequency characteristics to that of the single, suppressor tone. These results indicate that unmasking can be produced by CTs, just as if CTs were present in the stimulus. These data indirectly support the notion that CTs may be present in the form of traveling waves propagated along the basilar membrane.