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Hearing LossNCT00438334

Real-World Benefit From Directional Hearing Aids

A study testing Programmable directional/omni-directional hearing aid in people with Hearing Loss, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Directional microphone hearing aids have been shown to provide benefit for individuals with hearing loss in a number of laboratory experiments. However, few studies have investigated the real-world, subject-reported benefit from these hearing aids, and even fewer have examined directional hearing aid benefit across… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Hearing Loss
What is being tested?
Programmable directional/omni-directional hearing aid
Type of treatment
Medical device
How many people
105 participants
Where
1 siteUnited States
Study dates
Apr 2001to Mar 2004
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 105 subjects were recruited for participation in this study, thirty-five in each of three hearing loss groups.
  • Subjects were assigned to the three groups according to the severity of their hearing losses.
  • Group 1 (mild) subjects exhibited normal sloping to moderately severe SNHL, with Pure Tone Averages (PTAs) at 500, 1000, and 2000 Hz of less than 35 dB HL.
  • Group 2 (moderate) consisted of subjects with mild sloping to moderately severe SNHL with PTAs of 35 to 50 dB HL.
  • Group 3 (severe) subjects exhibited moderately-severe, sloping to severe-profound SNHL, with PTAs of greater than 50.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Department of Veterans Affairs Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Real-World Benefit From Directional Microphone Hearing Aids

Directional microphone hearing aids have been shown to provide benefit for individuals with hearing loss in a number of laboratory experiments. However, few studies have investigated the real-world, subject-reported benefit from these hearing aids, and even fewer have examined directional hearing aid benefit across varying degrees of hearing loss. This study will summarize data from a three-year, multi-faceted study of directional hearing aid benefit. Ninety four subjects were divided into three hearing loss groups (normal-to-moderate, mild-to-moderately-severe, and moderate-to-profound). These subjects were then fit with experimental hearing aids set to either directional or omnidirectional mode to determine if significant differences were present in hearing aid outcomes (both subjective and objective). Both subject and experimenter were blinded to the hearing aid settings. Following one month of use in each experimental setting, subjects completed: probe microphone measurements, speech understanding in noise testing, use questionnaires, subjective benefit scales, and satisfaction scales. At the conclusion of the study, subjects rated their preferences for the experimental settings in quiet, noise and overall. Both objective measures, as well as subjective data, were analyzed across hearing aid and hearing loss conditions.

Read the detailed description

Subjects- 105 subjects were recruited for participation in this study, thirty-five in each of three hearing loss groups. Subjects were assigned to the three groups according to the severity of their hearing losses. Group 1 (mild) subjects exhibited normal sloping to moderately severe SNHL, with Pure Tone Averages (PTAs) at 500, 1000, and 2000 Hz of less than 35 dB HL. Group 2 (moderate) consisted of subjects with mild sloping to moderately severe SNHL with PTAs of 35 to 50 dB HL. Group 3 (severe) subjects exhibited moderately-severe, sloping to severe-profound SNHL, with PTAs of greater than 50. All subjects had sloping hearing loss defined as at least a 20 dB average difference between 3000 Hz and 500 Hz. (Due to subject drop-out, the final data consisted of 32 subjects in the mild group, 33 in moderate group, and 29 in the severe group)

Hearing status was assessed by means of audiometric pure-tone and speech recognition testing in a group of previous hearing aid users. Normal middle ear function was verified by means of immittance measures. All subjects exhibited absence of significant air-bone gap at any frequency (<10 dB) and normal tympanograms defined as compensated static admittance between 0.25 and 2.5 mmho measured from the positive tail with tympanometric peak pressure between -150 and +100 daPa. All subjects were service-connected veterans who are eligible for care and amplification through the VA Audiology service. All subjects were previous wearers of binaural hearing aids, with a minimum daily usage requirement of 4 hours/day. All subjects were previous users of output compression hearing aids from the same manufacturer.

All subjects participated in approximately eight to ten hours of testing over the course of four visits. At the first visit, subjects received a hearing test, unaided speech understanding in noise measures, and aided speech understanding in noise with their current hearing aids. Additionally, earmold impressions were obtained for the experimental hearing aids. At the second visit, subjects completed the first set of subjective measures for the unaided and current (own) hearing aid conditions. Subjects were then fit with digitally programmable user-selectable directional/omnidirectional hearing aids in the first of two experimental settings (randomly selected between directional/omnidirectional and omnidirectional only), which they used for approximately one month before returning for the next test session. At the third visit, subjects again completed the entire test battery for the experimental hearing aid worn during the last month. The experimental hearing aid was then programmed for the other condition (directional/omnidirectional or omnidirectional only). At the fourth and final visit, subjects completed the entire test battery for this final hearing aid condition. Additionally, at the final visit, subjects completed a preference questionnaire.

Speech understanding in noise tests:

The Connected Sentence Test (CST) and the Hearing In Noise Test (HINT) were administered to all subjects. An investigator in the room with the subject scored the test. The investigator was blinded to the experimental settings of the hearing aids to control for experimenter bias. The CST is a test of speech intelligibility for everyday speech presented at a fixed SNR. The test consisted of 24 pairs of speech passages produced conversationally. The subject's task was to repeat all words of each test sentence. Each passage included 25 key words that were scored correct or incorrect. Subject scores from 1 pair of passages were averaged to obtain an intelligibility score for each experimental condition. Data from Pearsons et al. indicate that real-world SNRs in relatively noisy environments range from approximately +4 dB to -1 dB. Consequently, the tests were administered at a +3 dB SNR, which represented a relatively difficult real-world listening situation. This SNR was chosen to minimize floor and ceiling effects for all subject groups based on a previous investigation in our laboratory, given the steep performance-intensity function that has been reported for the CST.

The HINT was administered as a second test of sentence intelligibility in noise. For this investigation, two blocks of ten sentences were used for each condition. Listeners were required to repeat sentences spoken by a male talker in the presence of a speech-shaped noise, which was presented at a fixed level of 65 dBA. The level of the speech stimuli was adjusted adaptively until a Speech Reception Threshold (SRT) was determined. The SRT was defined as the SNR necessary for a listener to recognize the speech materials correctly 50 % of the time. Correct identification of each sentence was based on proper repetition of all words of the sentence, with minor exceptions. These exceptions related to the fact that small substitutions in verb tense and the articles "a" and "the" were allowed without scoring a sentence as incorrect. Presentation level of the sentences was adjusted based on the subjects' responses (an incorrect response raised the level; a correct response lowered the level for the next sentence). The level was varied in 4 dB steps for the first 5 trials, and 2 dB steps for the final 15 trials.

Speech in noise test environment:

The arrangement of the speakers for the speech-in-noise testing is shown in figure 1. Both of the speech-in-noise tests were administered in a conference room (5.05 X 4.71 X 2.60 meters) with moderate reverberation (average reverberation time Rt60: 482 ms, measured for octave frequencies from 250 through 4000 Hz, under experimental conditions with 2 people in the room). Each subject was seated in the center of the room with an eight-speaker configuration for the presentation of the speech and noise stimuli. Speech will be presented from a point-source loudspeaker (Tannoy System 600, fused-concentric driver) at a 0º azimuth. Uncorrelated noise was delivered from the seven bipolar loudspeakers (Definitive Technologies BP-2X) spaced equally about the listener [approximately 25, 76, 128, 180, 232, 284, 335]. The use of bipolar loudspeakers allowed for a more diffuse source position in comparison to standard, front-firing loudspeakers. All speakers were equidistant (1.5m) from the subject's head. Speech and noise levels were controlled using a Pentium IV class computer and an eight-channel level controller (Ashly VCM-88).

Hearing aid fitting protocol:

Hearing aid gain was determined using the National Acoustics Laboratory-Revised (NAL-R) prescriptive targets and verified using real-ear (Fonix 6500) measurements. Hearing aid frequency-gain parameters were adjusted so that the measured real ear aided response matched the target response as closely as possible for octave frequencies from 500 to 4000 Hz for both omnidirectional and directional modes. The matches to target are reported in the results. The processing strategy of the experimental hearing aids was set as output compression to match each subject's previous hearing aids. Targets were matched for a 65 dB SPL composite noise input. A real ear saturation response was obtained with a 90 dB SPL broadband input to ensure that high-level stimuli did not exceed listener discomfort levels, and the hearing aid output was adjusted accordingly. In order to maintain a double-blind experiment, the hearing aid programming, fitting, and real ear measurements were performed by one investigator who recorded how the hearing aid was set (omnidirectional or directional) for each visit. This investigator kept these data until the subject completed all aspects of the study. Furthermore, the investigator who programmed and fit the hearing aids was not involved in further data collection with that subject.

Since all subjects were previous users of binaural amplification, a brief orientation to the use of the experimental hearing aids should be sufficient. Subjects were issued a remote control with a volume control and three program buttons. Program 1 was set with the default setting (directional or omnidirectional). In order to ensure subject safety, an omnidirectional program was included in program two across both conditions; however, subjects were instructed only to use program two in situations where it was necessary to hear sounds from all angles equally (e.g. crossing the street in traffic, etc.). Program three on the remote control was set to mute, so that subjects could use only the first two programs. Subjects were be given identical instructions for both settings (omnidirectional and directional) and the investigator who gave the instructions did not know which setting was currently in the subject's hearing aids. Subjects were told that the hearing aids are likely to work best in noise if they could position themselves so that the signal of interest is in front of them and the interfering noise behind. Subjects were instructed on cleaning, care, battery usage, and volume control adjustment. Subjects were asked to wear the experimental hearing aids as much as possible during waking hours, minimally 6 hours/day. Subjects were asked to log their daily hearing aid use on a log sheet that will be provided to verify that they met the 6 hour/day. Additionally, subjects recorded how much time each day was spent in each of the two programs.

Subjective measures:

PHAB- The investigator who administered the subjective measures was masked as to the experimental settings of the hearing aids. All subjects completed the Profile of Hearing Aid Benefit (PHAB) questionnaire for each condition: unaided, previous aid, experimental directional, and experimental omnidirectional. The PHAB is a 66-item inventory that was developed for research usage to generate a measure of hearing aid benefit. Subjects completed the 66 items once for unaided listening and once for each aided condition. The test instrument was scored based on the benefit provided for aided versus unaided conditions.

SADL- All subjects completed the Satisfaction with Amplification in Daily Living (SADL) questionnaire for each of the three aided conditions. The SADL was designed to quantify satisfaction with hearing aids. This scale consists of 15 items in four subscales: positive effects of amplification, service and costs, negative features, and personal image. Subjects respond to questions about their general opinions of wearing hearing aids. For the current study, the 3 questions on cost and service were omitted, because the subjects did not pay for the hearing aids, only wore the experimental hearing aids for one month before completing the survey.

Preference questionnaire- At the conclusion of a subject's involvement in the study, he/she was asked which hearing aid was preferred for quiet and noisy environments as well as if she/he had an overall preference for any of the three hearing aid conditions.

Conditions
Hearing Loss
Being tested
Programmable directional/omni-directional hearing aid
Keywords
Benefit, Directional microphones, Hearing, Hearing aids, Hearing loss, Noise, Objective benefit, Signal-to-noise ratio, Speech understanding, Subjective benefit
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Programmable directional/omni-directional hearing aidDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probe microphone measurements

  2. Speech understanding in noise

  3. Hearing aid use time

  4. Hearing aid benefit

  5. Hearing aid preference

  6. Hearing aid satisfaction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2007 (estimated)
  2. Study startApr 2001
  3. Primary completionMar 2004
  4. Study completionMar 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00438334
Sponsor's protocol ID
000170
Status last verified
Nov 2016
First submitted
5 Dec 2006
Last updated
22 Nov 2016
Results posted
No

Publications

  • Gnewikow D, Ricketts T, Bratt GW, Mutchler LC. Real-world benefit from directional microphone hearing aids. J Rehabil Res Dev. 2009;46(5):603-18. doi: 10.1682/jrrd.2007.03.0052.

    PubMed 19882494

Questions about this trial

What is this clinical trial studying?

A study testing Programmable directional/omni-directional hearing aid in people with Hearing Loss, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probe microphone measurements. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00438334, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.

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Real-World Benefit From Directional Hearing Aids | AzTrials